PMA P870076S001

Device: FALOPE-RING(R) BAND CONTRACEPTIVE TUBAL OCCLUSION SYSTEM
Applicant: Gyrus Acmi, Inc.
PMA number: P870076
Supplement: S001
Product code: KNH
Decision date: 1996-01-02
Classification: Laparoscopic Contraceptive Tubal Occlusion Device
Generic name: Laparoscopic contraceptive tubal occlusion device
Approval order statement: APPROVAL FOR A CHANGE OF STERILIZATION FACILITY TO THE GRIFFITH MICROSCIENCE FACILITY IN WILLOWBROOK, ILLINOIS, FOR THE PRODUCTS INCLUDING THE DISPOSABLE FALOPE-RING APPLICATOR KIT WITH 8MM TROCAN DISPOSABLE TROCAR AND CANNULA, (REORDER NUMBER 005280-901), AND DISPOSABLE FALOPE-RING APPLICATOR KIT WITHOUT 8MM TROCAN DISPOSABLE TROCAR AND CANNULA, (REORDER NUMBER 006889-901)

Current openFDA PMA Record#

Device: FALOPE-RING(R) BAND CONTRACEPTIVE TUBAL OCCLUSION SYSTEM
Applicant: Gyrus Acmi, Inc.
PMA number: P870076
Supplement: S001
Product code: KNH
Generic name: Laparoscopic contraceptive tubal occlusion device
Decision date: 1996-01-02
Decision code: APPR
Date received: 1995-09-01
Supplement type: Normal 180 Day Track
Supplement reason: Location Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: APPROVAL FOR A CHANGE OF STERILIZATION FACILITY TO THE GRIFFITH MICROSCIENCE FACILITY IN WILLOWBROOK, ILLINOIS, FOR THE PRODUCTS INCLUDING THE DISPOSABLE FALOPE-RING APPLICATOR KIT WITH 8MM TROCAN DISPOSABLE TROCAR AND CANNULA, (REORDER NUMBER 005280-901), AND DISPOSABLE FALOPE-RING APPLICATOR KIT WITHOUT 8MM TROCAN DISPOSABLE TROCAR AND CANNULA, (REORDER NUMBER 006889-901)