POLYVIOLENE SUTURE

FDA Premarket Approval N80950 S003

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

DevicePOLYVIOLENE SUTURE
Generic NameSuture, Nonabsorbable, Synthetic, Polyester
ApplicantLOOK, INC.
Date Received1986-03-21
Decision Date1986-06-09
PMAN80950
SupplementS003
Product CodeGAS 
Advisory CommitteeGeneral & Plastic Surgery
Expedited ReviewNo
Combination Product No
Applicant Address LOOK, INC. 2020 Lonnie Abbott Industrial blvd. P.o.box 2087 ada, OK 74820

Supplemental Filings

Supplement NumberDateSupplement Type
N80950Original Filing
S003 1986-03-21
S002 1986-01-28
S001 1984-07-10

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.