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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameAPLIGRAF(R)(GRAFTSKIN)
Classification Namedressing, wound and burn, interactive
Generic Namegraftskin
ApplicantORGANOGENESIS, INC.
PMA NumberP950032
Supplement NumberS019
Date Received11/03/2000
Decision Date11/19/2001
Product Code
MGR[ Registered Establishments with MGR ]
Advisory Committee General & Plastic Surgery
Supplement Typereal-time process
Supplement Reason labeling change - minor
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for patient brochures for patients with chronic venous insufficiency and diabetic ulcers. The device, as modified, will be marketed under the trade name apligraf and is indicated for use with standard therapeutic compression for the treatment of non-infected partial and full-thickness skin ulcers due to venous insufficiency of greater than 1 month duration and which have not adequately responded to conventional ulcer therapy and for use with standard diabetic foot ulcer care for the treatment of full-thickness neuropathic diabetic foot ulcers of greater than three weeks duration which have not adequately responded to conventional ulcer therapy and which extend through the dermis but without tendon, muscle, capsule or bone exposure.
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