PMA P870076S003

Device: FALOPE-RING (R) BAND CONTRACEPTIVE TUBAL OCCLUSION SYSTEM
Applicant: Gyrus Acmi, Inc.
PMA number: P870076
Supplement: S003
Product code: KNH
Decision date: 1996-03-01
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 MEDICAL MANUFACTURING CORPORATION, ERIE, PENNSYLVANIA FOR THE PRODUCTS INCLUDING THE FALOPE-RING BAND:BOX OF 30 STERILE PROCEDURE KITS (REORDER NUJBER 000719-250), AND FALOPE-RING BAND: BOX OF 100 STERILE PROCEDURE KITS (REORDER NUMBER 001452-901)

Current openFDA PMA Record#

Device: FALOPE-RING (R) BAND CONTRACEPTIVE TUBAL OCCLUSION SYSTEM
Applicant: Gyrus Acmi, Inc.
PMA number: P870076
Supplement: S003
Product code: KNH
Generic name: Laparoscopic contraceptive tubal occlusion device
Decision date: 1996-03-01
Decision code: APPR
Date received: 1995-10-05
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 MEDICAL MANUFACTURING CORPORATION, ERIE, PENNSYLVANIA FOR THE PRODUCTS INCLUDING THE FALOPE-RING BAND:BOX OF 30 STERILE PROCEDURE KITS (REORDER NUJBER 000719-250), AND FALOPE-RING BAND: BOX OF 100 STERILE PROCEDURE KITS (REORDER NUMBER 001452-901)