PMA P870076S014

Device: FALOPE-RING BAND AND APPLICATOR SYSTEMS
Applicant: Gyrus Acmi, Inc.
PMA number: P870076
Supplement: S014
Product code: KNH
Decision date: 2014-11-17
Classification: Laparoscopic Contraceptive Tubal Occlusion Device
Generic name: Laparoscopic contraceptive tubal occlusion device
Approval order statement: APPROVAL FOR LABELING CLARIFICATIONS REGARDING NOT LOADING DEVICES MORE THAN THIRTY MINUTES BEFORE USE, AND REDUCING LANGUAGES IN DEVICE LABELING TO ONLY ENGLISH AND FRENCH.

Current openFDA PMA Record#

Device: FALOPE-RING BAND AND APPLICATOR SYSTEMS
Applicant: Gyrus Acmi, Inc.
PMA number: P870076
Supplement: S014
Product code: KNH
Generic name: Laparoscopic contraceptive tubal occlusion device
Decision date: 2014-11-17
Decision code: APPR
Date received: 2014-10-20
Supplement type: Special (Immediate Track)
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: APPROVAL FOR LABELING CLARIFICATIONS REGARDING NOT LOADING DEVICES MORE THAN THIRTY MINUTES BEFORE USE, AND REDUCING LANGUAGES IN DEVICE LABELING TO ONLY ENGLISH AND FRENCH.