NONABSORBABLE SURG. SUTURES, BRAIDED SILK

Suture, Nonabsorbable, Silk

FDA Premarket Approval N84348 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, BRAIDED SILK
Classification NameSuture, Nonabsorbable, Silk
Generic NameSuture, Nonabsorbable, Silk
ApplicantDEKNATEL, INC.
Date Received1987-06-09
Decision Date1988-07-14
PMAN84348
SupplementS002
Product CodeGAP
Advisory CommitteeGeneral & Plastic Surgery
Supplement TypeNormal 180 Day Track
Supplement ReasonLocation Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address DEKNATEL, INC. 600 Airport Rd. fall River, MA 02720

Supplemental Filings

Supplement NumberDateSupplement Type
N84348Original Filing
S006 1989-05-09 Normal 180 Day Track
S005 1988-03-31 Normal 180 Day Track
S004 1987-12-30 Normal 180 Day Track
S003 1987-09-18 Normal 180 Day Track
S002 1987-06-09 Normal 180 Day Track
S001 1980-09-23

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