- Device
- Integra Dermal Regeneration Template - Terminally Sterilized, Integra Meshed Dermal Regeneration Template - Terminally S
- Applicant
- Integra Lifesciences Corp.
- PMA number
- P900033
- Supplement
- S110
- Product code
- MGR
- Generic name
- Dressing, wound and burn, interactive
- Decision date
- 2023-10-26
- Decision code
- OK30
- Date received
- 2023-09-28
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- the qualification of changes to the Clean Compressed Air (CCA) System