Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
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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 | S004 |
Date Received | 06/12/2013 |
Decision Date | 07/10/2013 |
Product Code |
FTR |
Advisory Committee |
General & Plastic Surgery |
Supplement Type | 30-Day Notice |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement ELECTRONIC DATA ACQUISITION SYSTEM (EDA) INSTEAD OF VIA A CHART RECORDER. |
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