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.
 
DeviceDERMAGRAFT-TC(TM)
Generic NameDressing, wound and burn, interactive
ApplicantShire Regenerative Medicine
11095 Torreyana Rd.
San Diego, CA 92121
PMA NumberP960007
Supplement NumberS001
Date Received04/08/1997
Decision Date10/17/1997
Conversion Date08/14/2013
Product Code MGR 
Advisory Committee General & Plastic Surgery
Supplement TypeReal-Time Process
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for the new indication of partial thickness burns that are mid-dermal to indeterminate depth burn wounds that typically require debridement and that may be expected to heal without autografting.
-
-