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) | Registration & Listing | Adverse Events | Recalls | PMA | 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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameINTEGRA ARTIFICIAL SKIN
Classification Namedressing, wound and burn, interactive
Generic Nameartificial skin burn wound covering
ApplicantINTEGRA LIFESCIENCES CORP.
PMA NumberP900033
Supplement NumberS003
Date Received11/08/1999
Decision Date11/23/1999
Product Code
MGR[ Registered Establishments with MGR ]
Advisory Committee General & Plastic Surgery
Supplement Type30-day notice
Supplement Reason process change - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
The 30-day notice requested a change to the quality control test used to determine the chondroitin-6-sulfate content in integra(r) artificial skin, dermal regeneration template.
-
-