PMA P870076S026

Device: Falope-Ring® Band and Applicator Systems
Applicant: Gyrus Acmi, Inc.
PMA number: P870076
Supplement: S026
Product code: KNH
Decision date: 2021-05-11
Generic name: Laparoscopic contraceptive tubal occlusion device
Approval order statement: Approval for modifications to the labeling to assure the risks associated with damaged packaging and components identified in the Design Failure Mode and Effects Analysis are addressed in the instructions for use.

Current openFDA PMA Record#

Device: Falope-Ring® Band and Applicator Systems
Applicant: Gyrus Acmi, Inc.
PMA number: P870076
Supplement: S026
Product code: KNH
Generic name: Laparoscopic contraceptive tubal occlusion device
Decision date: 2021-05-11
Decision code: APPR
Date received: 2021-04-16
Supplement type: Special (Immediate Track)
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: Approval for modifications to the labeling to assure the risks associated with damaged packaging and components identified in the Design Failure Mode and Effects Analysis are addressed in the instructions for use.