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.
| Device | Falope-Ring® Band and Applicator Systems |
| Generic Name | Laparoscopic Contraceptive Tubal Occlusion Device |
| Applicant | Gyrus ACMI, Inc. |
| Date Received | 2021-04-16 |
| Decision Date | 2021-05-11 |
| PMA | P870076 |
| Supplement | S026 |
| Product Code | KNH |
| Advisory Committee | Obstetrics/Gynecology |
| Supplement Type | Special (immediate Track) |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| 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