|
Device | NATRELLE 410 Highly Cohesive Anatomically Shaped Silicone-Filled |
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 | S029 |
Date Received | 07/02/2018 |
Decision Date | 08/01/2018 |
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 Replace paper chart recorders and to use an electric heating module rather than water to heat the air in the carousel room. |