PMA P960007S016
- Device
- TRANSCYTE HUMAN FIBROBLAST-DERIVED TEMPORARY SKIN SUBSTITUTE
- Applicant
- Shire Regenerative Medicine
- PMA number
- P960007
- Supplement
- S016
- Product code
- MGR
- Decision date
- 2001-12-26
- Classification
- Dressing, Wound And Burn, Interactive
- Generic name
- Dressing, wound and burn, interactive
- Approval order statement
- APPROVAL FOR THE CEASING OF ENROLLMENT OF NEW PATIENTS IN THE POST-MARKET APPROVAL STUDY: TC-01-07-0597 "AN OPEN LABEL STUDY TO EVALUATE THE INCIDENCE OF WOUND INFECTION IN PATIENTS REQUIRING A TEMPORARY COVERING FOR EXCISED BURN WOUNDS"
Current openFDA PMA Record#
- Device
- TRANSCYTE HUMAN FIBROBLAST-DERIVED TEMPORARY SKIN SUBSTITUTE
- Applicant
- Shire Regenerative Medicine
- PMA number
- P960007
- Supplement
- S016
- Product code
- MGR
- Generic name
- Dressing, wound and burn, interactive
- Decision date
- 2001-12-26
- Decision code
- APPR
- Date received
- 2001-11-05
- Supplement type
- Real-Time Process
- Supplement reason
- Postapproval Study Protocol
- Approval order statement
- APPROVAL FOR THE CEASING OF ENROLLMENT OF NEW PATIENTS IN THE POST-MARKET APPROVAL STUDY: TC-01-07-0597 "AN OPEN LABEL STUDY TO EVALUATE THE INCIDENCE OF WOUND INFECTION IN PATIENTS REQUIRING A TEMPORARY COVERING FOR EXCISED BURN WOUNDS"