PMA P870076S022

Device: FALOPE RING BAND AND APPLICATOR SYSTEMS
Applicant: Gyrus Acmi, Inc.
PMA number: P870076
Supplement: S022
Product code: KNH
Decision date: 2017-02-21
Classification: Laparoscopic Contraceptive Tubal Occlusion Device
Generic name: Laparoscopic contraceptive tubal occlusion device
Approval order statement: Approval for a manufacturing site located at Ethox International, Inc., 2710 Northridge Drive NW Suite A, Grand Rapids, MI 49544-9112, as a packaging facility.

Current openFDA PMA Record#

Device: FALOPE RING BAND AND APPLICATOR SYSTEMS
Applicant: Gyrus Acmi, Inc.
PMA number: P870076
Supplement: S022
Product code: KNH
Generic name: Laparoscopic contraceptive tubal occlusion device
Decision date: 2017-02-21
Decision code: APPR
Date received: 2016-03-24
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 Ethox International, Inc., 2710 Northridge Drive NW Suite A, Grand Rapids, MI 49544-9112, as a packaging facility.