PMA P870076S013

Device: FALOPE-RING CAND AND APPLICATOR SYSTEMS
Applicant: Gyrus Acmi, Inc.
PMA number: P870076
Supplement: S013
Product code: KNH
Decision date: 2012-10-26
Classification: Laparoscopic Contraceptive Tubal Occlusion Device
Generic name: Laparoscopic contraceptive tubal occlusion device
Approval order statement: APPROVAL FOR LABELING CHANGES INCLUDING ADDING/ MODIFYING WARNINGS IN THE INSTRUCTION FOR USE, UPDATING COMPANY BRANDING, AND SEPARATING THE QUICK REFERENCE GUIDES FOR THE REUSABLE AND DISPOSABLE APPLICATORS.

Current openFDA PMA Record#

Device: FALOPE-RING CAND AND APPLICATOR SYSTEMS
Applicant: Gyrus Acmi, Inc.
PMA number: P870076
Supplement: S013
Product code: KNH
Generic name: Laparoscopic contraceptive tubal occlusion device
Decision date: 2012-10-26
Decision code: APPR
Date received: 2012-10-04
Supplement type: Special (Immediate Track)
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: APPROVAL FOR LABELING CHANGES INCLUDING ADDING/ MODIFYING WARNINGS IN THE INSTRUCTION FOR USE, UPDATING COMPANY BRANDING, AND SEPARATING THE QUICK REFERENCE GUIDES FOR THE REUSABLE AND DISPOSABLE APPLICATORS.