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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.
 
DeviceZYDERM COLLAGEN IMPLANT (ZYDERM CI)
Classification Nameimplant, dermal, for aesthetic use
Generic Nameimplant, dermal, for aesthetic use
Applicant
Allergan
71 south los carneros road
goleta, CA 93117-5506
PMA NumberP800022
Supplement NumberS025
Date Received08/26/1991
Decision Date09/30/1991
Product Code
LMH[ Registered Establishments with LMH ]
Advisory Committee General & Plastic Surgery
Supplement Typenormal 180 day track
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination Product No
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