DISPOSABLE FALOPE-RING BAND APPLICATOR KITS

Laparoscopic Contraceptive Tubal Occlusion Device

FDA Premarket Approval P870076 S019

This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.

Pre-market Approval Supplement Details

Change in suppliers from senior operations llc (formerly known as gormac products) to gyrus acmi norwalk, oh facility (establishment registration number 1519132) for the manufacture of the following components of your device: falope ring band applicator forceps inner tube (part number 005261); outer tube (part number 005262); and cannula sleeve (part number 004557-3).

• Device: DISPOSABLE FALOPE-RING BAND APPLICATOR KITS
• Classification Name: Laparoscopic Contraceptive Tubal Occlusion Device
• Generic Name: Laparoscopic Contraceptive Tubal Occlusion Device
• Applicant: Gyrus ACMI, Inc.
• Date Received: 2015-12-28
• Decision Date: 2016-01-27
• PMA: P870076
• Supplement: S019
• Product Code: KNH
• Advisory Committee: Obstetrics/Gynecology
• Supplement Type: 30-day Notice
• Supplement Reason: Process Change - Manufacturer/sterilizer/packager/supplier
• Expedited Review: No
• Combination Product: No
• Applicant Address: Gyrus ACMI, Inc. 136 Turnpike Rd. southborough, MA 01772

Supplemental Filings

Supplement Number	Date	Supplement Type
P870076		Original Filing
S027	2021-04-21	30-day Notice
S026	2021-04-16	Special (immediate Track)
S025	2020-04-03	30-day Notice
S024	2020-01-13	30-day Notice
S023	2016-07-18	Real-time Process
S022	2016-03-24	Normal 180 Day Track No User Fee
S021	2016-02-04	30-day Notice
S020	2016-01-13	30-day Notice
S019	2015-12-28	30-day Notice
S018	2015-12-08	Normal 180 Day Track No User Fee
S017	2015-11-02	Normal 180 Day Track
S016	2015-01-22	30-day Notice
S015	2014-11-05	30-day Notice
S014	2014-10-20	Special (immediate Track)
S013	2012-10-04	Special (immediate Track)
S012	2012-06-05	30-day Notice
S011	2010-06-15	30-day Notice
S010	2010-05-04	30-day Notice
S009	2010-01-27	30-day Notice
S008	2006-08-18	Normal 180 Day Track No User Fee
S007	1998-07-27	Normal 180 Day Track
S006	1997-03-11	Normal 180 Day Track
S005	1996-11-27	Normal 180 Day Track
S004	1996-02-07	Normal 180 Day Track
S003	1995-10-05	Normal 180 Day Track
S002
S001	1995-09-01	Normal 180 Day Track

NIH GUDID Devices

Device ID	PMA	Supp
00821925032996	P870076	000
00821925032989	P870076	000
00821925032972	P870076	000
00821925028852	P870076	000
00821925000186	P870076	000
00821925028913	P870076	000
00821925028869	P870076	000