PMA P950032S031
- Device
- APLIGRAF
- Applicant
- Organogenesis, Inc.
- PMA number
- P950032
- Supplement
- S031
- Product code
- MGR
- Decision date
- 2002-04-09
- Generic name
- Dressing, wound and burn, interactive
- Approval order statement
- APPROVAL FOR REVISIONS IN THE PRODUCT LABELING INCLUDING INCLUSION OF A STATEMENT CONCERNING THE VIRUS TESTING FOR EACH DONOR CELL STRAIN.
Current openFDA PMA Record#
- Device
- APLIGRAF
- Applicant
- Organogenesis, Inc.
- PMA number
- P950032
- Supplement
- S031
- Product code
- MGR
- Generic name
- Dressing, wound and burn, interactive
- Decision date
- 2002-04-09
- Decision code
- APPR
- Date received
- 2002-03-25
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- APPROVAL FOR REVISIONS IN THE PRODUCT LABELING INCLUDING INCLUSION OF A STATEMENT CONCERNING THE VIRUS TESTING FOR EACH DONOR CELL STRAIN.