PMA P950032S004
- Device
- APLIGRAF (GRAFTSKIN)
- Applicant
- Organogenesis, Inc.
- PMA number
- P950032
- Supplement
- S004
- Product code
- MGR
- Decision date
- 1999-01-06
- Classification
- Dressing, Wound And Burn, Interactive
- Generic name
- Dressing, wound and burn, interactive
- Approval order statement
- Response to conditions of approval cited in May 22, 1998, Approval Order: 1) Revisions in karyology, growth rate and morphology testing and 2) Protocol 98-VSU-002, "A Prospective Study to Determine the Longevity of Apligraf Cells on Patients with Venous Ulcers" as well as the cited methods for obtaining documentation of the viral inactivation processes for transferrin.
Current openFDA PMA Record#
- Device
- APLIGRAF (GRAFTSKIN)
- Applicant
- Organogenesis, Inc.
- PMA number
- P950032
- Supplement
- S004
- Product code
- MGR
- Generic name
- Dressing, wound and burn, interactive
- Decision date
- 1999-01-06
- Decision code
- APPR
- Date received
- 1998-10-28
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Postapproval Study Protocol
- Approval order statement
- Response to conditions of approval cited in May 22, 1998, Approval Order: 1) Revisions in karyology, growth rate and morphology testing and 2) Protocol 98-VSU-002, "A Prospective Study to Determine the Longevity of Apligraf Cells on Patients with Venous Ulcers" as well as the cited methods for obtaining documentation of the viral inactivation processes for transferrin.