PMA P960007S019
- Device
- TRANSCYTE HUMAN FIBROBLAST-DERIVED TEMPORARY SKIN SUBSTITUTE
- Applicant
- Shire Regenerative Medicine
- PMA number
- P960007
- Supplement
- S019
- Product code
- MGR
- Decision date
- 2010-08-25
- Generic name
- Dressing, wound and burn, interactive
- Approval order statement
- ELIMINATING AN ASSAY USED IN THE TRANSCYTE MANUFACTURING PROCESS.
Current openFDA PMA Record#
- Device
- TRANSCYTE HUMAN FIBROBLAST-DERIVED TEMPORARY SKIN SUBSTITUTE
- Applicant
- Shire Regenerative Medicine
- PMA number
- P960007
- Supplement
- S019
- Product code
- MGR
- Generic name
- Dressing, wound and burn, interactive
- Decision date
- 2010-08-25
- Decision code
- OK30
- Date received
- 2010-07-26
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- ELIMINATING AN ASSAY USED IN THE TRANSCYTE MANUFACTURING PROCESS.