|
Device | FILSHIE CLIP (MARK VI) SYSTEM |
Generic Name | Laparoscopic contraceptive tubal occlusion device |
Regulation Number | 884.5380 |
Applicant | FEMCARE LTD. 32 Premier Way Romsey SO51 |
PMA Number | P920046 |
Supplement Number | S009 |
Date Received | 03/09/2016 |
Decision Date | 09/09/2016 |
Product Code |
KNH |
Advisory Committee |
Obstetrics/Gynecology |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for changing MR Conditional to 3T. |