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 has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DeviceINTEGRA DERMAL REGENERATION TEMPLATE
Generic NameDressing, wound and burn, interactive
ApplicantIntegra LifeSciences Corp.
105 MORGAN LN.
PLAINSBORO, NJ 08536
PMA NumberP900033
Date Received05/07/1990
Decision Date03/01/1996
Product Code MGR 
Docket Number 96M-0203
Notice Date 07/18/1996
Advisory Committee General & Plastic Surgery
Expedited Review Granted? No
Combination ProductNo
RecallsCDRH Recalls
Approval Order Statement  
APPROVAL FOR THE INTEGRA ARTIFICAL SKIN
Supplements:  S001 S002 S003 S005 S006 S007 S008 S009 S010 S011 S012 
S013 S014 S015 S016 S017 S018 S019 S020 S021 S022 S023 S024 
S025 S026 S027 S028 S029 S030 S031 S032 S033 S034 S035 S037 
S038 S039 S040 S041 S042 S043 S044 S045 S046 S047 S048 S051 
S053 S054 S055 S056 S057 S058 S059 S060 S061 S062 S063 S065 
S066 S067 S068 S069 S070 S071 S072 S073 S074 S075 S076 S077 
S078 S079 S080 S081 S082 S083 S084 S085 S086 S089 S090 S091 
S092 S093 S094 S095 S096 S097 S098 S099 S100 S101 S102 S103 
S104 S105 S106 S107 S108 S109 S110 S111 
-
-