PMA P900033S117

Device: INTEGRA ® Dermal Regeneration Template, Integra® Meshed Dermal Regeneration Template, and Integra® Omnigraft Dermal Rege
Applicant: Integra Lifesciences Corp.
PMA number: P900033
Supplement: S117
Product code: MGR
Decision date: 2026-09-18
Classification: General, Plastic Surgery
Generic name: Dressing, wound and burn, interactive
Approval order statement: installation and qualification of a new Water for Injection (WFI) pretreatment, generation, storage, and distribution system

Current openFDA PMA Record#

Device: INTEGRA ® Dermal Regeneration Template, Integra® Meshed Dermal Regeneration Template, and Integra® Omnigraft Dermal Rege
Applicant: Integra Lifesciences Corp.
PMA number: P900033
Supplement: S117
Product code: MGR
Generic name: Dressing, wound and burn, interactive
Decision date: 2026-09-18
Decision code: OK30
Date received: 2026-08-21
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: installation and qualification of a new Water for Injection (WFI) pretreatment, generation, storage, and distribution system