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 Saline-Filled Breast Implants |
Generic Name | Prosthesis, breast, inflatable, internal, saline |
Regulation Number | 878.3530 |
Applicant | Allergan 2525 DUPONT DR. IRVINE, CA 92612 |
PMA Number | P990074 |
Supplement Number | S041 |
Date Received | 10/02/2017 |
Decision Date | 11/03/2017 |
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 Implement an Electronic Data Acquisition (EDA) System to collect cycle parameter, such as temperature and time, for the shell drying after washing and gel curing after shell filling occur in the Blue-M oven. The above change is located 900 Parkway Global Park, La Aurora, Heredia, Costa Rica. |
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