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 | IDEAL IMPLANT SALINE-FILLED BREAST IMPLANT |
Generic Name | prosthesis, breast, inflatable, internal, saline |
Regulation Number | 878.3530 |
Applicant | IDEALIMPLANT 14881 quorum drive suite 925 dallas, TX 75254 |
PMA Number | P120011 |
Supplement Number | S005 |
Date Received | 04/15/2016 |
Decision Date | 05/13/2016 |
Product Code |
FWM |
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 Manufacturing sequence change: baffle shell slitting process was moved to follow the 2-inch hole die-cutting step, instead of preceding it. The facility is located in Specialty Silicone Fabricators (SSF), 2761 Walnut Avenue, Tustin, CA 92780. |
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