NONABSORBABLE SURG. SUTURES, NYLON

Suture, Nonabsorbable, Synthetic, Polyamide

FDA Premarket Approval N85060 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

DeviceNONABSORBABLE SURG. SUTURES, NYLON
Classification NameSuture, Nonabsorbable, Synthetic, Polyamide
Generic NameSuture, Nonabsorbable, Synthetic, Polyamide
ApplicantDEKNATEL, INC.
Date Received1984-06-21
Decision Date1985-02-27
PMAN85060
SupplementS002
Product CodeGAR
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
N85060Original Filing
S007 1989-05-09 Normal 180 Day Track
S006 1988-03-31 Normal 180 Day Track
S005 1987-12-30 Normal 180 Day Track
S004 1987-09-18 Normal 180 Day Track
S003 1987-06-09 Normal 180 Day Track
S002 1984-06-21
S001 1980-09-23

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