• 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 NameAPILGRAF(GRAFTSKIN)
Classification Namedressing, wound and burn, interactive
Generic Namegraftskin
ApplicantORGANOGENESIS, INC.
PMA NumberP950032
Supplement NumberS028
Date Received10/24/2001
Decision Date01/17/2002
Product Code
MGR[ Registered Establishments with MGR ]
Advisory Committee General & Plastic Surgery
Supplement Typenormal 180 day track
Supplement Reason other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for removal of the cmv igg antibody test from the antepartum maternal donor serum testing panel, while continuing to test the maternal donor sera for cmv igm antibodies and the master cell bank for cmv via pcr.
-
-