|
Device | NATRELLE HIGHLY COHESIVE 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 | P040046 |
Supplement Number | S006 |
Date Received | 01/17/2014 |
Decision Date | 02/14/2014 |
Product Code |
FTR |
Advisory Committee |
General & Plastic Surgery |
Supplement Type | 30-day notice |
Supplement Reason | process change - manufacturer/sterilizer/packager/supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement CHANGE IN THE STERILIZATION VALIDATION METHOD, INCLUDING A CHANGE IN THE D-VALUE OF THE BIOLOGICAL INDICATORS AND A CHANGE IN THE VALIDATION PROTOCOL METHOD. |