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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.
 
DeviceGORE-TEX(R) SUTURE
Generic NameSuture, nonabsorbable, synthetic, polypropylene
Regulation Number878.5010
ApplicantW. L. Gore & Associates, Inc.
1500 N. Fourth St.
P.O. Box 3000
Flagstaff, AZ 86003
PMA NumberP820083
Supplement NumberS021
Date Received09/03/1996
Decision Date09/24/1996
Product Code GAW 
Advisory Committee General & Plastic Surgery
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR COMBINING EPTFE PLEDGETS WITH GORE-TEX SUTURE AND APPROVAL FOR MODIFIED PACKAGING OF THE GORE-TEX SUTURE
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