PMA P960007S003
- Device
- DERMAGRAFT-TC(TM)
- Applicant
- Shire Regenerative Medicine
- PMA number
- P960007
- Supplement
- S003
- Product code
- MGR
- Decision date
- 1997-11-24
- Classification
- Dressing, Wound And Burn, Interactive
- Generic name
- Dressing, wound and burn, interactive
- Approval order statement
- Approval for a change of Dermagraft-TC storage conditions to include -20C frost-free freezers.
Current openFDA PMA Record#
- Device
- DERMAGRAFT-TC(TM)
- Applicant
- Shire Regenerative Medicine
- PMA number
- P960007
- Supplement
- S003
- Product code
- MGR
- Generic name
- Dressing, wound and burn, interactive
- Decision date
- 1997-11-24
- Decision code
- APPR
- Date received
- 1997-10-22
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Postapproval Study Protocol
- Approval order statement
- Approval for a change of Dermagraft-TC storage conditions to include -20C frost-free freezers.