PMA P950032S043
- Device
- APLIGRAF
- Applicant
- Organogenesis, Inc.
- PMA number
- P950032
- Supplement
- S043
- Product code
- MGR
- Decision date
- 2006-04-21
- Generic name
- Dressing, wound and burn, interactive
- Approval order statement
- APPROVAL FOR A CHANGE IN PRODUCT EXPIRATION DATING FROM 5 DAYS AT 20-37DEGREES C TO 15 DAYS AT 20-23 DEGREES C.
Current openFDA PMA Record#
- Device
- APLIGRAF
- Applicant
- Organogenesis, Inc.
- PMA number
- P950032
- Supplement
- S043
- Product code
- MGR
- Generic name
- Dressing, wound and burn, interactive
- Decision date
- 2006-04-21
- Decision code
- APPR
- Date received
- 2006-03-02
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- APPROVAL FOR A CHANGE IN PRODUCT EXPIRATION DATING FROM 5 DAYS AT 20-37DEGREES C TO 15 DAYS AT 20-23 DEGREES C.