|
Device | NATRELLE 410 Highly Cohesive Anatomically Shaped 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 | S025 |
Date Received | 07/20/2017 |
Decision Date | 08/21/2017 |
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 to Limulous Amoebocyte Lysate (LAL) reagent sensitivity |