Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
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Device | FALOPE-RING (R) BAND CONTRACEPTIVE TUBAL OCCLUSION SYSTEM |
Generic Name | Laparoscopic contraceptive tubal occlusion device |
Regulation Number | 884.5380 |
Applicant | Gyrus ACMI, Inc. 136 TURNPIKE RD. SOUTHBOROUGH, MA 01772 |
PMA Number | P870076 |
Supplement Number | S004 |
Date Received | 02/07/1996 |
Decision Date | 06/14/1996 |
Product Code |
KNH |
Advisory Committee |
Obstetrics/Gynecology |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Location Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR AN ALTERNATE MANUFACTURING SITE ON CIRCON-CABOT MEDICAL'S RACINE, WISCONSIN FACILITY FOR 1) DISPOSABLE FALOPE-RING APPLICATOR KIT WITH 8MM TROCAR DISPOSABLE TROCAR, AND CANNULA: BOX OF 8 STERILE PROCEDURE KITS (RE-ORDER NUMBER 005280-901); AND 2) DISPOSABLE FALOPE-RING APPLICATOR KIT WITHOUT 8MM TROCAR, DISPOSABLE TROCAR, AND CANNULA: BOX OF 8 STERILE PROCEDURE KITS (RE-ORDER NUMBER 006889-901) |
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