PMA P950032S046
- Device
- APLIGRAF
- Applicant
- Organogenesis, Inc.
- PMA number
- P950032
- Supplement
- S046
- Product code
- MGR
- Decision date
- 2008-03-19
- Generic name
- Dressing, wound and burn, interactive
- Approval order statement
- APPROVAL FOR THE INTRODUCTION OF ADDITIONAL IN-PROCESS BIOBURDEN TESTING AND QUALITY ASSURANCE STEPS TO ENHANCE THE SAFETY PROFILE OF APLIGRAF.
Current openFDA PMA Record#
- Device
- APLIGRAF
- Applicant
- Organogenesis, Inc.
- PMA number
- P950032
- Supplement
- S046
- Product code
- MGR
- Generic name
- Dressing, wound and burn, interactive
- Decision date
- 2008-03-19
- Decision code
- APPR
- Date received
- 2008-03-10
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL FOR THE INTRODUCTION OF ADDITIONAL IN-PROCESS BIOBURDEN TESTING AND QUALITY ASSURANCE STEPS TO ENHANCE THE SAFETY PROFILE OF APLIGRAF.