PMA P900033S106
- Device
- INTEGRA® Dermal Regeneration Template and Integra® Meshed Dermal Regeneration Template
- Applicant
- Integra Lifesciences Corp.
- PMA number
- P900033
- Supplement
- S106
- Product code
- MGR
- Decision date
- 2023-04-18
- Classification
- General, Plastic Surgery
- Generic name
- Dressing, wound and burn, interactive
- Approval order statement
- Endotoxin unit change from EU/ml to EU/Device per revised USP <161>.
Current openFDA PMA Record#
- Device
- INTEGRA® Dermal Regeneration Template and Integra® Meshed Dermal Regeneration Template
- Applicant
- Integra Lifesciences Corp.
- PMA number
- P900033
- Supplement
- S106
- Product code
- MGR
- Generic name
- Dressing, wound and burn, interactive
- Decision date
- 2023-04-18
- Decision code
- OK30
- Date received
- 2023-03-20
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Endotoxin unit change from EU/ml to EU/Device per revised USP .