PMA P900033S116

Device: INTEGRA ® Dermal Regeneration Template; Integra® Meshed Dermal Regeneration Template; Integra® Omnigraft Dermal Regenera
Applicant: Integra Lifesciences Corp.
PMA number: P900033
Supplement: S116
Product code: MGR
Decision date: 2026-02-25
Classification: General, Plastic Surgery
Generic name: Dressing, wound and burn, interactive
Approval order statement: the qualification of the autoclave batch record reporting configuration generated by the Supervisory Control and Data Acquisition (SCADA) Process Control System (PCS).

Current openFDA PMA Record#

Device: INTEGRA ® Dermal Regeneration Template; Integra® Meshed Dermal Regeneration Template; Integra® Omnigraft Dermal Regenera
Applicant: Integra Lifesciences Corp.
PMA number: P900033
Supplement: S116
Product code: MGR
Generic name: Dressing, wound and burn, interactive
Decision date: 2026-02-25
Decision code: OK30
Date received: 2026-01-26
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: the qualification of the autoclave batch record reporting configuration generated by the Supervisory Control and Data Acquisition (SCADA) Process Control System (PCS).