AdVance"Male Sling System

  • Modèle / numéro de série
    REF 720088-01 Lot/Serial # 878849001 to 904928030 REF 720163-01 Lot/Serial # 767189001 to 905578100
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Worldwide Distribution-US (nationwide) including DC and Puerto Rico and the countries of AUSTRIA, BELGIUM, CROATIA, CECH REPUBLIC, ESTONIA, FINLAND, FRANCE, GERMANY, GREECE, IRELAND, ISRAEL, ITALY, LEBANON, NETHERLANDS, NORWAY, POLAND, PORTUGAL, SAUDI ARABIA, SLOVENIA, SERBIA, SOUTH AFRICA, SPAIN. SWEDEN, SWITZERLAND, TURKEY, UNITED KINGDOM, CHILE, COLUMBIA, COSTA RICA, HONG KONG, MALAYSIA, MARTINIQUE, NEW ZEALAND, PANAMA, PHILIPPINES, SINGAPORE, THAILAND, VENEZUELA, CANADA, AUSTRALIA.
  • Description du dispositif
    AdVance"Male Sling System, REF 720088-01 & || AdVance" XP Male Sling System REF 720163-01 || (not commercially available in the US) || The AdVance Male Sling System consists of two, sterile single-use surgical instruments called helical needle passers and a mesh sling with attached connectors. One end of each helical needle passer is keyed to allow a secure attachment of the sling connectors. The sling mesh is constructed of polypropylene monofilament mesh that is precut to 1.2 centimeters arm width, 3.55 centimeters center width, and 35.5 centimeters length. Two absorbable tensioning sutures are threaded into the length of the mesh. Plastic sheaths are placed over each arm of the mesh to aide in ease of placement. The connectors are attached to the ends of the helical needle passers during the procedure. The mesh and suture portions of the sling are intended to remain in the body as a permanent implant and the mesh component is not absorbed or degraded by the action of tissue in-growth or tissue enzymes.
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    American Medical Systems, Inc., 10700 Bren Rd W, Minnetonka MN 55343-9679
  • Source
    USFDA