PMA P900033S098

Device: Integra® Dermal Regeneration Template, Integra® Meshed Dermal Regeneration Template and Integra® Omnigraft Dermal Regene
Applicant: Integra Lifesciences Corp.
Product code: MGR
Decision date: 2022-05-17
Generic name: Dressing, wound and burn, interactive
Approval order statement: Approval for the qualification of a new Scanning Electron Microscope (SEM) for imaging Integra Dermal Regeneration Template (IDRT) product samples for pore size analysis.

Current openFDA PMA Record#

Device: Integra® Dermal Regeneration Template, Integra® Meshed Dermal Regeneration Template and Integra® Omnigraft Dermal Regene
Applicant: Integra Lifesciences Corp.
PMA number: P900033
Supplement: S098
Product code: MGR
Generic name: Dressing, wound and burn, interactive
Decision date: 2022-05-17
Decision code: APPR
Date received: 2021-12-15
Supplement type: 135 Review Track For 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Approval for the qualification of a new Scanning Electron Microscope (SEM) for imaging Integra Dermal Regeneration Template (IDRT) product samples for pore size analysis.