NOVAFIL(TM)

Suture, Nonabsorbable, Synthetic, Polyester

FDA Premarket Approval P840041 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

DeviceNOVAFIL(TM)
Classification NameSuture, Nonabsorbable, Synthetic, Polyester
Generic NameSuture, Nonabsorbable, Synthetic, Polyester
ApplicantDAVIS & GECK, INC.
Date Received1987-04-14
Decision Date1987-06-05
PMAP840041
SupplementS002
Product CodeGAS
Advisory CommitteeGeneral & Plastic Surgery
Supplement TypeNormal 180 Day Track
Supplement ReasonLocation Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address DAVIS & GECK, INC. one Casper St. danbury, CT 06810

Supplemental Filings

Supplement NumberDateSupplement Type
P840041Original Filing
S006 1995-12-19 Special (immediate Track)
S005 1993-10-04 Normal 180 Day Track
S004 1989-06-09 Normal 180 Day Track
S003 1988-03-21 Normal 180 Day Track
S002 1987-04-14 Normal 180 Day Track
S001 1986-11-04 Normal 180 Day Track

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