|
Device | FEMCARE FILSHIE CLIP |
Generic Name | Laparoscopic contraceptive tubal occlusion device |
Regulation Number | 884.5380 |
Applicant | FEMCARE LTD. 32 Premier Way Romsey SO51 |
PMA Number | P920046 |
Supplement Number | S006 |
Date Received | 12/02/2008 |
Decision Date | 01/30/2009 |
Product Code |
KNH |
Advisory Committee |
Obstetrics/Gynecology |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR A CHANGE TO THE SILICONE PROFILE OF THE DEVICE. |