Approval for the filshie clip system (mark vi). The device is a contraceptive tubal occlusion device (tod)
Device | FILSHIE CLIP (MARK VI) SYSTEM |
Classification Name | Laparoscopic Contraceptive Tubal Occlusion Device |
Generic Name | Laparoscopic Contraceptive Tubal Occlusion Device |
Applicant | FEMCARE LTD. |
Date Received | 1992-09-10 |
Decision Date | 1996-09-05 |
Notice Date | 1996-12-09 |
PMA | P920046 |
Supplement | S |
Product Code | KNH |
Docket Number | 96M-0463 |
Advisory Committee | Obstetrics/Gynecology |
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