PMA P870076S004

Device: FALOPE-RING (R) BAND CONTRACEPTIVE TUBAL OCCLUSION SYSTEM
Applicant: Gyrus Acmi, Inc.
PMA number: P870076
Supplement: S004
Product code: KNH
Decision date: 1996-06-14
Classification: Laparoscopic Contraceptive Tubal Occlusion Device
Generic name: Laparoscopic contraceptive tubal occlusion device
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)

Current openFDA PMA Record#

Device: FALOPE-RING (R) BAND CONTRACEPTIVE TUBAL OCCLUSION SYSTEM
Applicant: Gyrus Acmi, Inc.
PMA number: P870076
Supplement: S004
Product code: KNH
Generic name: Laparoscopic contraceptive tubal occlusion device
Decision date: 1996-06-14
Decision code: APPR
Date received: 1996-02-07
Supplement type: Normal 180 Day Track
Supplement reason: Location Change - Manufacturer/Sterilizer/Packager/Supplier
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)