- Device
- INTEGRA Dermal Regeneration Template, Integra Meshed Dermal Regeneration Template and Integra Omnigraft Dermal Regenerat
- Applicant
- Integra Lifesciences Corp.
- PMA number
- P900033
- Supplement
- S095
- Product code
- MGR
- Generic name
- Dressing, wound and burn, interactive
- Decision date
- 2021-11-13
- Decision code
- APPR
- Date received
- 2021-05-24
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for the qualification of an additional abattoir (harvesting facility) for New Zealand sourced bovine tendon.