• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Premarket Approval (PMA)

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | Registration & Listing | Adverse Events | Recalls | PMA | Classification | Standards | Inspections
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
Trade NameADCON-L ANTI-ADHESION CONTROL IN A BARRIER GEL
Classification Nameinhibitor, peridural fibrosis (adhesion barrier)
Generic Nameinhibitor, peridural fibrosis
ApplicantWRIGHTMEDICALTECHNOLOGYINC
PMA NumberP960057
Date Received12/23/1996
Decision Date05/27/1998
Withdrawal Date 05/09/2007
Product Code
MLQ[ Registered Establishments with MLQ ]
Docket Number 98M-0404
Notice Date 06/23/1998
Advisory Committee Physical Medicine
Expedited Review Granted? Yes
Combination Product No
Approval Order Statement 
Approval for adcon(r)-l adhesion barrier gel. This device is indicated for use during single level, posterior lumbar laminectomy or laminotomy procedures where nerve roots are exposed to inhibit postsurgical peridural fibrosis.
Supplements: S001 S002 S003 S004 S005 S006 S008 S011 
-
-