|
Device | Filshie Clip 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 | S013 |
Date Received | 04/12/2023 |
Decision Date | 12/18/2023 |
Product Code |
KNH |
Advisory Committee |
Obstetrics/Gynecology |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Location Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement approval for transfer of manufacturing and packaging processes for the Filshie Clip |