AMS 800¿ Urinary Control System. The AMS 800¿ Urinary Control System is used to treat urinary incontinence due to reduced outlet resistance (intrinsic sphincter deficiency) following prostate surgery. The AMS 800¿ Urinary Control System is an implantable, fluid filled, solid silicone elastomer device used to treat stress urinary incontinence. It is designed to restore the natural process of urinary control. The device simulates normal sphincter function by opening and closing the urethra at the control of the patient. The AMS 800 system consists of three inter connected components: a cuff, a pump, and a pressure-regulating balloon. The three components are connected with kink-resistant tubing. The AMS 800 can be implanted at either the bulbous urethra or the bladder neck.

Detalles del retiro

Fabricante

American Medical Systems, Inc.

Distribuidor

Worldwide Distribution -- Nationwide Distribution including the states of AL, AZ, AR, CA, CO, CT, DE, FL, GA, IL, IN, IA, KS, KY LA, ME, MD, MA, MI, MN, MS, MO, MT, NE, NH, NJ, NM, NY,NC, OH, OK, OR, PA, PR, RI, SC, TN, TX, UT, VT, VA, WA and WI., and the countries of AUSTRIA, AUSTRALIA, CANADA, BELGIUM, SWITZERLAND, CZECH REPUBLIC, GERMANY, DENMARK, ESTONIA, SPAIN, FINLAND, FRANCE, GREAT BRITAIN, IRELAND, ITALY, LEBANON, NETHERLANDS, NORWAY, SWEDEN, TURKEY, ARGENTINA, BRAZIL, IVORY COST, COLOMBIA, ECUADOR, INDIA, JAPAN, MEXICO, NEW ZEALAND, PANAMA and VENEZUELA.

Lote

Model # Lot # 720172-01 737875001 720172-01 737875002 720172-01 737875003 720172-01 737875004 72400098 714613001 72400098 714613002 72400098 714613003 72400098 714613004 72400098 714613005 72400098 714613006 72400098 714613007 72400098 714613008 72400098 714613009 72400098 714613010 72400098 714613011 72400098 714613013 72400098 714613014 72400098 714613015 72400098 714631001 72400098 714631002 72400098 714631003 72400098 714631004 72400098 714631005 72400098 714631006 72400098 714631007 72400098 714631008 72400098 714631009 72400098 714631010 72404127 786981017 72400098 714631014 72400098 714631015 72400098 714631016 72400098 714631017 72400098 714631018 72400098 714631019 72400098 714631020 72400098 714644001 72400098 714644002 72400098 714644003 72400098 714644004 72400098 714644005 72400098 714644007 72400098 714644008 72400098 714644009 72400098 714644010 72400098 714644011 72400098 714644012 72400098 714644013 72400098 714644014 72400098 714644015 72400098 714644016 72400098 714644017 72400098 714660001 72400098 714660002 72400098 714660003 72400098 714660004 72400098 714660005 72400098 714660007 72400098 714660008 72400098 714660010 72400098 714660012 72400098 714660013 72400098 714660016 72400098 714660017 72400098 714660018 72400098 714660019 72400098 716228001 72400098 716228002 72400098 716228003 72400098 716228004 72400098 716228005 72400098 716228006 72400098 716228007 72400098 716228008 72400098 716228009 72400098 716228010 72400098 716228011 72400098 716228012 72400098 716228013 72400098 716228014 72400098 716228015 72400098 716228016 72400098 716228017 72400098 717297001 72400098 717297002 72400098 717297003 72400098 717297004 72400098 717297005 72400098 717297006 72400098 717297007 72400098 717297008 72400098 717297009 72400098 717297010 72400098 717297011 72400098 717297012 72400098 717297013 72400098 717297014 72400098 717297015 72400098 717297016 72400098 717297017 72400098 717297018 72400098 717297019 72400098 719372001 72400098 719372002 72400098 719372003 72400098 719372004 72400098 719372005 72400098 719372006 72400098 719372007 72400098 719372008 72400098 719372009 72400098 719372010 72400098 719372011 72400098 719372012 72400098 719372013 72400098 719372014 72400098 719372015 72400098 719372016 72400098 719372017 72400098 719372018 72400098 719372019 72400098 731325001 72400098 731325002 72400098 731325003 72400098 731325005 72400098 731325007 72400098 731325008 72400098 731325009 72400098 731325010 72400098 731325011 72400098 731325012 72400098 731325016 72400098 731325017 72400098 731325019 72400098 731325020 72400098 733301001 72400098 733301002 72400098 733301003 72400098 733301004 72400098 733301005 72400098 733301006 72400098 733301007 72400098 733301008 72400098 733301009 72400098 733301010 72400098 733301011 72400098 733301012 72400098 733301013 72400098 733301014 72400098 733301015 72400098 733301016 72400098 733301017 72400098 733301018 72400098 733995001 72400098 733995002 72400098 733995003 72400098 733995004 72400098 733995005 72400098 733995006 72400098 733995007 72400098 733995008 72400098 733995009 72400098 733995010 72400098 733995011 72400098 733995012 72400098 733995013 72400098 733995014 72400098 733995015 72400098 733995016 72400098 735549001 72400098 735549002 72400098 735549003 72400098 735549004 72400098 735549005 72400098 735549006 72400098 735549007 72400098 735549008 72400098 735549009 72400098 735549010 72400098 735549011 72400098 735549012 72400098 735549013 72400098 735549014 72400098 735549015 72400098 735549016 72400098 735551001 72400098 735551002 72400098 735551003 72400098 735551004 72400098 735551005 72400098 735551006 72400098 735551007 72400098 735551008 72400098 735551009 72400098 735551010 72400098 735551011 72400098 735551012 72400098 735551013 72400098 7355

Clasificación de riesgo

Class II

Área (FDA)

device

País

United States