PMA P900033S115

Device: INTEGRA® Dermal Regeneration Template, Integra® Meshed Dermal Regeneration Template, and Integra® Omnigraft Dermal Regen
Applicant: Integra Lifesciences Corp.
PMA number: P900033
Supplement: S115
Product code: MGR
Decision date: 2025-09-09
Classification: General, Plastic Surgery
Generic name: Dressing, wound and burn, interactive
Approval order statement: reclassifying cleanroom for Integra Dermal Regeneration Template (IDRT) product family

Current openFDA PMA Record#

Device: INTEGRA® Dermal Regeneration Template, Integra® Meshed Dermal Regeneration Template, and Integra® Omnigraft Dermal Regen
Applicant: Integra Lifesciences Corp.
PMA number: P900033
Supplement: S115
Product code: MGR
Generic name: Dressing, wound and burn, interactive
Decision date: 2025-09-09
Decision code: OK30
Date received: 2025-08-18
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: reclassifying cleanroom for Integra Dermal Regeneration Template (IDRT) product family