PMA P000036S014
- Device
- DERMAGRAFT
- Applicant
- Shire Regenerative Medicine
- PMA number
- P000036
- Supplement
- S014
- Product code
- MGR
- Decision date
- 2013-02-28
- Generic name
- Dressing, wound and burn, interactive
- Approval order statement
- APPROVAL FOR A CHANGE IN THE INTRA-UNIT SAMPLING REGIMEN FOR DERMAGRAFT ANALYTICAL RELEASE ASSAYS.
Current openFDA PMA Record#
- Device
- DERMAGRAFT
- Applicant
- Shire Regenerative Medicine
- PMA number
- P000036
- Supplement
- S014
- Product code
- MGR
- Generic name
- Dressing, wound and burn, interactive
- Decision date
- 2013-02-28
- Decision code
- APPR
- Date received
- 2012-12-21
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL FOR A CHANGE IN THE INTRA-UNIT SAMPLING REGIMEN FOR DERMAGRAFT ANALYTICAL RELEASE ASSAYS.