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 BREST 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 | S029 |
Date Received | 05/30/2014 |
Decision Date | 02/11/2015 |
Product Code |
FWM |
Advisory Committee |
General & Plastic Surgery |
Supplement Type | normal 180 day track no user fee |
Supplement Reason | location change - manufacturer/sterilizer/packager/supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR A MANUFACTURING SITE LOCATED AT PRO-TECH DESIGN AND MANUFACTURING, INC., IN ARLINGTON, TEXAS. |
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