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.
 
DeviceINTEGRA(R) DERMAL REGENERATION TEMPLATE, INTEGRA(R) MESHED DERMAL REGENERATION TEMPLATE
Generic NameDevice, dermal replacement
ApplicantIntegra LifeSciences Corp.
105 MORGAN LN.
PLAINSBORO, NJ 08536
PMA NumberP900033
Supplement NumberS053
Date Received11/03/2015
Decision Date05/09/2016
Product Codes MDD MGR 
Advisory Committee General & Plastic Surgery
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval of two new product sizes (i.e., 4cm x 4cm and 7cm x 7cm) and revised packaging that permits inclusion of a stapler and staples in the Integra Omnigraft Dermal Regeneration Matrix kit. The device, as modified, will be marketed under the trade name Omnigraft Dermal Regeneration Matrix.
-
-