MAXON(TM) POLYGLYCONATE MONOFILAMENT ABSORBABLE SU

FDA Premarket Approval P840051 S004

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

DeviceMAXON(TM) POLYGLYCONATE MONOFILAMENT ABSORBABLE SU
Generic NameSuture, Absorbable, Synthetic, Polyglycolic Acid
ApplicantDAVIS & GECK, INC.
Date Received1991-02-20
Decision Date1991-03-29
PMAP840051
SupplementS004
Product CodeGAM 
Advisory CommitteeGeneral & Plastic Surgery
Supplement TypeNormal 180 Day Track
Supplement ReasonLabeling Change - Indications/instructions/shelf Life/tradename
Expedited ReviewNo
Combination Product No
Applicant Address DAVIS & GECK, INC. 1 Casper St. danbury, CT 06810

Supplemental Filings

Supplement NumberDateSupplement Type
P840051Original Filing
S008 1996-10-30 Real-time Process
S007 1995-12-19 Special (immediate Track)
S006 1991-10-02 Normal 180 Day Track
S005 1991-08-07 Normal 180 Day Track
S004 1991-02-20 Normal 180 Day Track
S003 1989-05-15 Normal 180 Day Track
S002
S001 1987-04-14 Normal 180 Day Track

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