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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Trade NameGORE-TEX{TM} CRUCIATE LIGAMENT PROSTHESIS
Classification Nameprosthesis, ligament, ptfe
Generic Nameligament prosthesis, ptfe
ApplicantW.L. GORE & ASSOCIATES,INC
PMA NumberP850074
Supplement NumberS004
Date Received07/11/1988
Decision Date12/12/1988
Product Code
LWA
Advisory Committee Orthopedic
Supplement Typenormal 180 day track
Supplement Reason labeling change - other
Expedited Review Granted? No
Combination Product No
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