PMA P950032S067
- Device
- APLIGRAF
- Applicant
- Organogenesis, Inc.
- PMA number
- P950032
- Supplement
- S067
- Product code
- MGR
- Decision date
- 2012-02-22
- Generic name
- Dressing, wound and burn, interactive
- Approval order statement
- APPROVAL FOR THE INTRODUCTION OF HUMAN EPIDERMAL KERATINOCYTE CELL STRAIN (HEP 158) INTO THE MANUFACTURE OF THE DEVICE.
Current openFDA PMA Record#
- Device
- APLIGRAF
- Applicant
- Organogenesis, Inc.
- PMA number
- P950032
- Supplement
- S067
- Product code
- MGR
- Generic name
- Dressing, wound and burn, interactive
- Decision date
- 2012-02-22
- Decision code
- APPR
- Date received
- 2012-02-01
- 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 (HEP 158) INTO THE MANUFACTURE OF THE DEVICE.