- Device
- INTEGRA® Dermal Regeneration Template and Integra® Meshed Dermal Regeneration Template
- Applicant
- Integra Lifesciences Corp.
- PMA number
- P900033
- Supplement
- S103
- Product code
- MGR
- Generic name
- Dressing, wound and burn, interactive
- Decision date
- 2022-12-07
- Decision code
- OK30
- Date received
- 2022-11-14
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Change to the Water for Injection distribution System located at the Collagen Manufacturing Center.