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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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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.
 
DeviceSALINE-FILLED BREAST IMPLANTS
Generic Nameprosthesis, breast, inflatable, internal, saline
Regulation Number878.3530
Applicant
Allergan
2525 dupont dr.
irvine, CA 92612
PMA NumberP990074
Supplement NumberS006
Date Received04/17/2001
Decision Date05/15/2001
Product Code FWM 
Advisory Committee General & Plastic Surgery
Supplement Typenormal 180 day track
Supplement Reason express gmp supplement
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
APPROVAL FOR MOVING THE MANUFACTURING AND DRY HEAT STERILIZATION OF SALINE-FILLED BREAST IMPLANTS TO MCGHAN MEDICAL CORPORATION, SANTA BARBARA, CALIFORNIA.
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