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 Biologics Premarket Approvals (PMAs) 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.
 
Device Dermagraft
Classification Namecultured human cell skin dressing
Generic Namepfc
Applicant
Organogenesis, Inc.
150 dan road
Canton , MA 02021 
  
PMA NumberBP003600
Supplement NumberS047
Date Received07/30/2021
Decision Date08/26/2021
Decision 30-Day Notice - No 135-Day Supplement Needed
Product Code
PFC[ Registered Establishments with PFC ]
Advisory Committee General & Plastic Surgery
Supplement Type30-Day Notice
Expedited Review Granted? No
Third Party Review Elligble? No
Combination ProductNo
-
-