Approval for revisions to the instructions for use to clarify symptomatic versus asymptomatic clip migration rates for the filshie clip (mark vi) system.
| Device | Filshie Clip (Mark VI) System |
| Generic Name | Laparoscopic Contraceptive Tubal Occlusion Device |
| Applicant | FEMCARE LTD. |
| Date Received | 2021-12-08 |
| Decision Date | 2022-01-06 |
| PMA | P920046 |
| Supplement | S012 |
| 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 | FEMCARE LTD. stuart Court, Spursholt Place, Salisbury Rd romsey hampshire SO516 |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P920046 | | Original Filing |
| S012 |
2021-12-08 |
Special (immediate Track) |
| S011 |
2019-04-12 |
Normal 180 Day Track No User Fee |
| S010 |
2017-03-01 |
Real-time Process |
| S009 |
2016-03-09 |
Normal 180 Day Track |
| S008 |
2014-06-09 |
Normal 180 Day Track |
| S007 |
2008-12-01 |
30-day Notice |
| S006 |
2008-12-02 |
Real-time Process |
| S005 |
2008-04-14 |
Normal 180 Day Track No User Fee |
| S004 | | |
| S003 | | |
| S002 | | |
| S001 | | |
NIH GUDID Devices