DEKLENE(TM)

Suture, Nonabsorbable, Synthetic, Polyethylene

FDA Premarket Approval P810028 S002

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.

Pre-market Approval Supplement Details

DeviceDEKLENE(TM)
Classification NameSuture, Nonabsorbable, Synthetic, Polyethylene
Generic NameSuture, Nonabsorbable, Synthetic, Polyethylene
ApplicantDEKNATEL, INC.
Date Received1983-05-26
Decision Date1983-11-17
PMAP810028
SupplementS002
Product CodeGAT
Advisory CommitteeGeneral & Plastic Surgery
Expedited ReviewNo
Combination Product No
Applicant Address DEKNATEL, INC. 600 Airport Rd. fall River, MA 02720

Supplemental Filings

Supplement NumberDateSupplement Type
P810028Original Filing
S011 1989-05-09 Normal 180 Day Track
S010 1988-12-20 Normal 180 Day Track
S009 1988-03-31 Normal 180 Day Track
S008 1987-12-30 Normal 180 Day Track
S007 1987-09-18 Normal 180 Day Track
S006 1987-06-09 Normal 180 Day Track
S005 1984-09-07
S004 1984-06-21
S003 1983-06-15
S002 1983-05-26
S001 1983-04-26

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