- Device
- Dermal Regeneration Template, Integra Meshed Dermal Regeneration Template and Integra Omnigraft Dermal Regeneration Matr
- Applicant
- Integra Lifesciences Corp.
- PMA number
- P900033
- Supplement
- S070
- Product code
- MGR
- Generic name
- Dressing, wound and burn, interactive
- Decision date
- 2018-05-17
- Decision code
- OK30
- Date received
- 2018-04-20
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Change in the environmental monitoring procedures for detection of bioburden at the main cleanroom manufacturing area.