Approval for labeling changes including adding/ modifying warnings in the instruction for use, updating company branding, and separating the quick reference guides for the reusable and disposable applicators.
| Device | FALOPE-RING CAND AND APPLICATOR SYSTEMS |
| Classification Name | Laparoscopic Contraceptive Tubal Occlusion Device |
| Generic Name | Laparoscopic Contraceptive Tubal Occlusion Device |
| Applicant | Gyrus ACMI, Inc. |
| Date Received | 2012-10-04 |
| Decision Date | 2012-10-26 |
| PMA | P870076 |
| Supplement | S013 |
| 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