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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 may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
DeviceDERMAGRAFT
Classification Namedressing, wound and burn, interactive
Generic Namedressing, wound and burn, interactive
Applicant
SHIRE REGENERATIVE MEDICINE
11095 torreyana road
san diego, CA 92121
PMA NumberP000036
Date Received08/25/2000
Decision Date09/28/2001
Product Code
MGR[ Registered Establishments with MGR ]
Docket Number 01M-0498
Notice Date 10/31/2001
Advisory Committee General & Plastic Surgery
Expedited Review Granted? No
Combination Product Yes
Recalls CDRH 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 Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling
Supplements: S002 S003 S006 S007 S008 S009 S010 S011 S012 
S013 S014 S016 S017 S018 
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