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 Dermal Regeneration Template and Integra Meshed Dermal Regeneration Template
Generic NameDressing, wound and burn, interactive
ApplicantIntegra Lifesciences Corp.
105 Morgan Ln.
Plainsboro, NJ 08536
PMA NumberP900033
Supplement NumberS083
Date Received07/29/2019
Decision Date08/28/2019
Product Code MGR 
Advisory Committee General & Plastic Surgery
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Change to the Water for Injection Pretreatment System for INTEGRA Dermal Regeneration Template and INTEGRA Meshed Dermal Regeneration Template.
-
-