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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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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.
 
DeviceDERMAGRAFT
Generic Namedressing, wound and burn, interactive
ApplicantSHIRE REGENERATIVE MEDICINE
11095 torreyana road
san diego, CA 92121
PMA NumberP000036
Date Received08/25/2000
Decision Date09/28/2001
Conversion Date 08/14/2013
Product Code MGR 
Docket Number 01M-0498
Notice Date 10/31/2001
Advisory Committee General & Plastic Surgery
Expedited Review Granted? No
Combination ProductYes
RecallsCDRH Recalls
Approval Order Statement  
APPROVAL FOR THE DERMAGRAFT(R). THE DEVICE IS INDICATED FOR USE IN THE TREATMENT OF FULL-THICKNESS DIABETIC FOOT ULCERS GREATER THAN SIX WEEKS DURATION WHICH EXTEND THROUGH THE DERMIS, BUT WITHOUT TENDON MUSCLE, JOINT CAPSULE OR BONE EXPOSURE. DERMAGRAFT(R) SHOULD BE USED IN CONJUNCTION WITH STANDARD WOUND CARE REGIMENS AND IN PATIENTS THAT HAVE ADEQUATE BLOOD SUPPLY TO THE INVOLVED FOOT.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Supplements:  S002 S003 S006 S007 S008 S009 S010 S011 S012 S013 S014 
S016 S017 S018 
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