PMA P900033S074
- Device
- Integra Dermal Regeneration Template - Terminally Sterilized
- Applicant
- Integra Lifesciences Corp.
- PMA number
- P900033
- Supplement
- S074
- Product code
- MGR
- Decision date
- 2018-12-06
- Classification
- Dressing, Wound And Burn, Interactive
- Generic name
- Dressing, wound and burn, interactive
- Approval order statement
- Approval for a change to the Girton Tray Washer and its components.
Current openFDA PMA Record#
- Device
- Integra Dermal Regeneration Template - Terminally Sterilized
- Applicant
- Integra Lifesciences Corp.
- PMA number
- P900033
- Supplement
- S074
- Product code
- MGR
- Generic name
- Dressing, wound and burn, interactive
- Decision date
- 2018-12-06
- Decision code
- APPR
- Date received
- 2018-08-31
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for a change to the Girton Tray Washer and its components.