• 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 | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC | Inspections
 


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 NameTRANSCYTE (DERMAGRAFT-TC)
Classification Namedressing, wound and burn, interactive
Generic Namebioengineered temporary covering
ApplicantADVANCED TISSUE SCIENCES
PMA NumberP960007
Supplement NumberS009
Date Received07/24/1998
Decision Date12/01/1998
Product Code
MGR[ Registered Establishments with MGR ]
Advisory Committee General & Plastic Surgery
Supplement Typenormal 180 day track
Supplement Reason process change - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval that the atp assay be used in place of the mtt assay as a means of monitoring and predicting product characteristics. The product release criteria of the atp assay stipulate that production lots of transcyte will be harvested between incubation days 12 to 16 and must have an atp value in the range of 0. 083 to 0. 127 moles per bioreactor to be considered an acceptable lot.
-
-