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. |
|
Device | Sientra OPUS 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 | S015 |
Date Received | 01/07/2019 |
Decision Date | 04/17/2019 |
Product Code |
FTR |
Advisory Committee |
General & Plastic Surgery |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for new round implant styles 10621-XP, 10721-XP, 20621- XP, and 20721-XP. |
|
|