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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 MAMMARY PROSTHESIS AND SPECTRUM POST-OPERATIVELY ADJUSTABLE SALINE-FILLED MAMMARY PROSTHESIS
ApplicantMENTOR WORLDWIDE LLC
33 Technology Drive
Irvine, CA 92618
PMA NumberP990075
Supplement NumberS001
Date Received06/08/2000
Decision Date02/27/2001
Advisory Committee General & Plastic Surgery
Supplement TypeNormal 180 Day Track
Supplement Reason Postapproval Study Protocol
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR THE MENTOR SALINE AND SPECTRUM MAMMARY PROSTHESES RETRIEVAL PROTOCOL.
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