PMA P950032S070
- Device
- APLIGRAF
- Applicant
- Organogenesis, Inc.
- PMA number
- P950032
- Supplement
- S070
- Product code
- MGR
- Decision date
- 2014-03-10
- Classification
- Dressing, Wound And Burn, Interactive
- Generic name
- Dressing, wound and burn, interactive
- Approval order statement
- APPROVAL OF AN ALTERNATE SOURCE OF A CRITICAL MATERIAL USED IN THE MANUFACTURE OF APLIGRAF.
Current openFDA PMA Record#
- Device
- APLIGRAF
- Applicant
- Organogenesis, Inc.
- PMA number
- P950032
- Supplement
- S070
- Product code
- MGR
- Generic name
- Dressing, wound and burn, interactive
- Decision date
- 2014-03-10
- Decision code
- APPR
- Date received
- 2012-12-13
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL OF AN ALTERNATE SOURCE OF A CRITICAL MATERIAL USED IN THE MANUFACTURE OF APLIGRAF.