PMA P950032S062
- Device
- APLIGRAF
- Applicant
- Organogenesis, Inc.
- PMA number
- P950032
- Supplement
- S062
- Product code
- MGR
- Decision date
- 2011-02-10
- Generic name
- Dressing, wound and burn, interactive
- Approval order statement
- ALTERNATE SUPPLIER FOR THE POLYCARBONATE BASE FILM USED IN THE MANUFACTURE OF A CULTURE INSERT.
Current openFDA PMA Record#
- Device
- APLIGRAF
- Applicant
- Organogenesis, Inc.
- PMA number
- P950032
- Supplement
- S062
- Product code
- MGR
- Generic name
- Dressing, wound and burn, interactive
- Decision date
- 2011-02-10
- Decision code
- OK30
- Date received
- 2011-01-11
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- ALTERNATE SUPPLIER FOR THE POLYCARBONATE BASE FILM USED IN THE MANUFACTURE OF A CULTURE INSERT.