PMA P870076S018

Device: FALOPE-RING BAND CONTRACEPTIVE TUBAL OCCLUSION SYSTEM
Applicant: Gyrus Acmi, Inc.
PMA number: P870076
Supplement: S018
Product code: KNH
Decision date: 2016-03-22
Classification: Laparoscopic Contraceptive Tubal Occlusion Device
Generic name: Laparoscopic contraceptive tubal occlusion device
Approval order statement: Approval for a manufacturing site located at 9600 Louisiana Avenue North, Brooklyn Park, MN 55445 for the production of the Falope Ring Band.

Current openFDA PMA Record#

Device: FALOPE-RING BAND CONTRACEPTIVE TUBAL OCCLUSION SYSTEM
Applicant: Gyrus Acmi, Inc.
PMA number: P870076
Supplement: S018
Product code: KNH
Generic name: Laparoscopic contraceptive tubal occlusion device
Decision date: 2016-03-22
Decision code: APPR
Date received: 2015-12-08
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Location Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Approval for a manufacturing site located at 9600 Louisiana Avenue North, Brooklyn Park, MN 55445 for the production of the Falope Ring Band.