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 | SIENTRA SILICONE GEL BREAST IMPLANTS |
Generic Name | Prosthesis, breast, noninflatable, internal, silicone gel-filled |
Regulation Number | 878.3540 |
Applicant | SIENTRA, INC 6769 HOLLISTER AVENUE SUITE 201 SANTA BARBARA, CA 93117 |
PMA Number | P070004 |
Supplement Number | S007 |
Date Received | 12/12/2013 |
Decision Date | 01/08/2014 |
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 CHANGES TO THE MATERIAL OF THE BREAST IMPLANT MOLDS. |
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