PMA P960007S014
- Device
- TRANSCYTE(TM)
- Applicant
- Shire Regenerative Medicine
- PMA number
- P960007
- Supplement
- S014
- Product code
- MGR
- Decision date
- 2000-05-19
- Classification
- Dressing, Wound And Burn, Interactive
- Generic name
- Dressing, wound and burn, interactive
- Approval order statement
- APPROVAL TO CONDUCT THE FINAL PRODUCT STERILITY TEST IN-HOUSE UNDER THE CONDITIONS OF AN ISOLATOR ENVIRONMENT.
Current openFDA PMA Record#
- Device
- TRANSCYTE(TM)
- Applicant
- Shire Regenerative Medicine
- PMA number
- P960007
- Supplement
- S014
- Product code
- MGR
- Generic name
- Dressing, wound and burn, interactive
- Decision date
- 2000-05-19
- Decision code
- APPR
- Date received
- 2000-03-01
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL TO CONDUCT THE FINAL PRODUCT STERILITY TEST IN-HOUSE UNDER THE CONDITIONS OF AN ISOLATOR ENVIRONMENT.