PMA P950032S016
- Device
- APLIGRAF (GRAFTSKIN)
- Applicant
- Organogenesis, Inc.
- PMA number
- P950032
- Supplement
- S016
- Product code
- MGR
- Decision date
- 2000-06-20
- Classification
- Dressing, Wound And Burn, Interactive
- Generic name
- Dressing, wound and burn, interactive
- Approval order statement
- APPROVAL 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.
- Summary
- <a href="http://www.accessdata.fda.gov/cdrh_docs/pdf/P950032S016B.pdf" target="_new">Summary of Safety and Effectiveness</a>
Current openFDA PMA Record#
- Device
- APLIGRAF (GRAFTSKIN)
- Applicant
- Organogenesis, Inc.
- PMA number
- P950032
- Supplement
- S016
- Product code
- MGR
- Generic name
- Dressing, wound and burn, interactive
- Decision date
- 2000-06-20
- Decision code
- APPR
- Date received
- 1999-12-23
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- APPROVAL 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.