ADCON-L ADHESION CONTROL IN A BARRIER GEL

Inhibitor, Peridural Fibrosis (adhesion Barrier)

FDA Premarket Approval P960057 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

Approval for a patient brochure. The device is indicated for use during single level, posterior lumbar laminotomy procedures where nerve roots are exposed to inhibit postsurgical peridural fibrosis.

DeviceADCON-L ADHESION CONTROL IN A BARRIER GEL
Classification NameInhibitor, Peridural Fibrosis (adhesion Barrier)
Generic NameInhibitor, Peridural Fibrosis (adhesion Barrier)
ApplicantWRIGHTMEDICALTECHNOLOGYINC
Date Received1999-02-11
Decision Date1999-08-11
PMAP960057
SupplementS004
Product CodeMLQ
Advisory CommitteePhysical Medicine
Supplement TypeNormal 180 Day Track
Supplement ReasonLabeling Change - Indications/instructions/shelf Life/tradename
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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