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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.
 
DeviceDEKLENE(TM)
Generic NameSuture, nonabsorbable, synthetic, polyethylene
Regulation Number878.5000
ApplicantDeknatel, Inc.
600 Airport Rd.
Fall River, MA 02720
PMA NumberP810028
Supplement NumberS010
Date Received12/20/1988
Decision Date02/02/1989
Product Code GAT 
Advisory Committee General & Plastic Surgery
Supplement TypeNormal 180 Day Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
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