PMA P000036S007
- Device
- DERMAGRAFT
- Applicant
- Shire Regenerative Medicine
- PMA number
- P000036
- Supplement
- S007
- Product code
- MGR
- Decision date
- 2010-03-26
- Generic name
- Dressing, wound and burn, interactive
- Approval order statement
- REMOVAL OF THE IN PROCESS ASSAY FROM THE DERMAGRAFT MANUFACTURING PROCESS.
Current openFDA PMA Record#
- Device
- DERMAGRAFT
- Applicant
- Shire Regenerative Medicine
- PMA number
- P000036
- Supplement
- S007
- Product code
- MGR
- Generic name
- Dressing, wound and burn, interactive
- Decision date
- 2010-03-26
- Decision code
- OK30
- Date received
- 2010-03-02
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- REMOVAL OF THE IN PROCESS ASSAY FROM THE DERMAGRAFT MANUFACTURING PROCESS.