ADCON -L ADHESION CONTROL IN A BARRIER GEL

Inhibitor, Peridural Fibrosis (adhesion Barrier)

FDA Premarket Approval P960057 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

Approval for a change in adcon-l kit packaging configuration, i. E. , replacing the aluminum tube with a polypropylene syringe, and replacing the pvc application with a polypropylene applicator.

DeviceADCON -L ADHESION CONTROL IN A BARRIER GEL
Classification NameInhibitor, Peridural Fibrosis (adhesion Barrier)
Generic NameInhibitor, Peridural Fibrosis (adhesion Barrier)
ApplicantWRIGHTMEDICALTECHNOLOGYINC
Date Received1998-11-03
Decision Date1998-11-25
PMAP960057
SupplementS002
Product CodeMLQ
Docket NumberN
Advisory CommitteePhysical Medicine
Supplement TypeReal-time Process
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address WRIGHTMEDICALTECHNOLOGYINC 5677 Airline Rd. arlinton, TN 38002

Supplemental Filings

Supplement NumberDateSupplement Type
P960057Original Filing
S011 2000-06-26 Special (immediate Track)
S010
S009
S008 1999-05-13 Special (immediate Track)
S007
S006 1999-03-12 Real-time Process
S005 1999-02-19 135 Review Track For 30-day Notice
S004 1999-02-11 Normal 180 Day Track
S003 1998-12-21 30-day Notice
S002 1998-11-03 Real-time Process
S001 1998-08-28 30-day Notice

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