|
Device | NATRELLE SILICONE-FILLED BREAST IMPLANTS |
Generic Name | prosthesis, breast, noninflatable, internal, silicone gel-filled |
Regulation Number | 878.3540 |
Applicant | Allergan 2525 dupont dr. irvine, CA 92612 |
PMA Number | P020056 |
Supplement Number | S008 |
Date Received | 08/18/2008 |
Decision Date | 11/04/2008 |
Product Code |
FTR |
Advisory Committee |
General & Plastic Surgery |
Supplement Type | normal 180 day track no user fee |
Supplement Reason | postapproval study protocol - osb |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL. |