PMA P900033S113

Device: INTEGRA Dermal Regeneration Template, Integra Meshed Dermal Regeneration Template, and Integra Omnigraft Dermal Regenera
Applicant: Integra Lifesciences Corp.
PMA number: P900033
Supplement: S113
Product code: MGR
Decision date: 2025-02-18
Classification: General, Plastic Surgery
Generic name: Dressing, wound and burn, interactive
Approval order statement: for the qualification of the Building 105 Supervisory Application Control and Data Acquisition (SCADA) system and the modifications to the four existing AT Kettle thermocouples

Current openFDA PMA Record#

Device: INTEGRA Dermal Regeneration Template, Integra Meshed Dermal Regeneration Template, and Integra Omnigraft Dermal Regenera
Applicant: Integra Lifesciences Corp.
PMA number: P900033
Supplement: S113
Product code: MGR
Generic name: Dressing, wound and burn, interactive
Decision date: 2025-02-18
Decision code: OK30
Date received: 2025-01-21
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: for the qualification of the Building 105 Supervisory Application Control and Data Acquisition (SCADA) system and the modifications to the four existing AT Kettle thermocouples