|
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 | S012 |
Date Received | 12/08/2021 |
Decision Date | 01/06/2022 |
Product Code |
KNH |
Advisory Committee |
Obstetrics/Gynecology |
Supplement Type | Special (Immediate Track) |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for revisions to the Instructions for Use to clarify symptomatic versus asymptomatic clip migration rates for the Filshie Clip (Mark VI) System. |