Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • 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) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
Note: 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.
 
DeviceADCON -L ADHESION CONTROL IN A BARRIER GEL
Generic NameInhibitor, peridural fibrosis (adhesion barrier)
ApplicantWrightmedicaltechnologyinc
5677 Airline Rd.
Arlington, TN 38002
PMA NumberP960057
Supplement NumberS003
Date Received12/21/1998
Decision Date01/14/1999
Withdrawal Date05/09/2007
Product Code MLQ 
Advisory Committee Physical Medicine
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
The 30-Day Notice requested a change in the water temperature, mixing time and mixing speed used in the manufacturing process for the Adcon(R)-L Adhesion Control Barrier Gel. The proposed modifications are designed to increase the efficiency of the gel manufacturing process.
-
-