PMA P950032S069
- Device
- APLIGRAF
- Applicant
- Organogenesis, Inc.
- PMA number
- P950032
- Supplement
- S069
- Product code
- MGR
- Decision date
- 2012-11-20
- Generic name
- Dressing, wound and burn, interactive
- Approval order statement
- APPROVAL FOR THE INTRODUCTION OF HUMAN EPIDERMAL KERATINOCYTE CELL STRAIN 200 (HEP 200) INTO THE MANUFACTURE OF THE DEVICE.
Current openFDA PMA Record#
- Device
- APLIGRAF
- Applicant
- Organogenesis, Inc.
- PMA number
- P950032
- Supplement
- S069
- Product code
- MGR
- Generic name
- Dressing, wound and burn, interactive
- Decision date
- 2012-11-20
- Decision code
- APPR
- Date received
- 2012-10-31
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR THE INTRODUCTION OF HUMAN EPIDERMAL KERATINOCYTE CELL STRAIN 200 (HEP 200) INTO THE MANUFACTURE OF THE DEVICE.