|
Device | MCGHAN SALINE-FILLED BREAST IMPLANTS |
Generic Name | prosthesis, breast, inflatable, internal, saline |
Regulation Number | 878.3530 |
Applicant | Allergan 2525 dupont dr. irvine, CA 92612 |
PMA Number | P990074 |
Supplement Number | S015 |
Date Received | 06/05/2003 |
Decision Date | 07/22/2003 |
Product Code |
FWM |
Advisory Committee |
General & Plastic Surgery |
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 A MANUFACTURING SITE LOCATED AT INAMED CORPORATION, WICKLOW, IRELAND. |