This medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original pma or panel track supplement and may not represent the most recent labeling.
| Device | FALOPE RING BAND AND APPLICATOR SYSTEMS |
| Classification Name | Laparoscopic Contraceptive Tubal Occlusion Device |
| Generic Name | Laparoscopic Contraceptive Tubal Occlusion Device |
| Applicant | Gyrus ACMI, Inc. |
| Date Received | 1987-12-07 |
| Decision Date | 1993-09-29 |
| Notice Date | 1993-11-10 |
| PMA | P870076 |
| Supplement | S |
| Product Code | KNH |
| Docket Number | 93M-0381 |
| Advisory Committee | Obstetrics/Gynecology |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Gyrus ACMI, Inc. 136 Turnpike Rd. southborough, MA 01772 |
| 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 |
| Device ID | PMA | Supp |
|---|---|---|
| 00821925032996 | P870076 | 000 |
| 00821925032989 | P870076 | 000 |
| 00821925032972 | P870076 | 000 |
| 00821925028852 | P870076 | 000 |
| 00821925000186 | P870076 | 000 |