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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 IMPLANT
Generic NameProsthesis, breast, inflatable, internal, saline
Regulation Number878.3530
ApplicantAllergan
2525 Dupont Dr.
Irvine, CA 92612
PMA NumberP990074
Supplement NumberS003
Date Received11/29/2000
Decision Date12/15/2000
Product Code FWM 
Advisory Committee General & Plastic Surgery
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
CHANGE IN THE PRODUCT LAL TESTING FROM A RELEASE TEST FOR EVERY STERILIZATION LOT, TO A MANUFACTURING CHANGE CONTROL TOOL USED FOR PROCESS AND MATERIAL CHANGES. THERE WILL BE NO ADVERSE EFFECT TO THE DEVICE AS A RESULT OF CHANGING THE LAL TESTING FROM A RELEASE TEST TO A QUALIFICATION TEST. HISTORICAL RECORDS OF LAL TESTING ON FINISHED PRODUCT DEMONSTRATE THE PRODUCT MANUFACTURING PROCESS IS CONTROLLED AND PREDICTABLE, DELIVERING AN ENDOTOXIN-FREE PRODUCT.
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