Falope-Ring® Band and Applicator Systems

FDA Premarket Approval P870076 S026

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

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.

DeviceFalope-Ring® Band and Applicator Systems
Generic NameLaparoscopic Contraceptive Tubal Occlusion Device
ApplicantGyrus ACMI, Inc.
Date Received2021-04-16
Decision Date2021-05-11
PMAP870076
SupplementS026
Product CodeKNH 
Advisory CommitteeObstetrics/Gynecology
Supplement TypeSpecial (immediate Track)
Supplement ReasonLabeling Change - Indications/instructions/shelf Life/tradename
Expedited ReviewNo
Combination Product No
Applicant Address Gyrus ACMI, Inc. 136 Turnpike Rd. southborough, MA 01772

Supplemental Filings

Supplement NumberDateSupplement Type
P870076Original 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 IDPMASupp
00821925032996 P870076 000
00821925032989 P870076 000
00821925032972 P870076 000
00821925028852 P870076 000
00821925000186 P870076 000

© 2021 FDA.report
This site is not affiliated with or endorsed by the FDA.