PMA P900033S080

Device: Integra Dermal Regeneration Template, Integra Meshed Dermal Regeneration Template and Integra Omnigraft Dermal Regenerat
Applicant: Integra Lifesciences Corp.
PMA number: P900033
Supplement: S080
Product code: MGR
Decision date: 2019-05-07
Classification: Dressing, Wound And Burn, Interactive
Generic name: Dressing, wound and burn, interactive
Approval order statement: Qualification of two (2) new Total Organic Carbon (TOC) Analyzers at the Quality Control (QC) Analytical Laboratory at the Collagen Manufacturing Center (CMC).

Current openFDA PMA Record#

Device: Integra Dermal Regeneration Template, Integra Meshed Dermal Regeneration Template and Integra Omnigraft Dermal Regenerat
Applicant: Integra Lifesciences Corp.
PMA number: P900033
Supplement: S080
Product code: MGR
Generic name: Dressing, wound and burn, interactive
Decision date: 2019-05-07
Decision code: OK30
Date received: 2019-04-08
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Qualification of two (2) new Total Organic Carbon (TOC) Analyzers at the Quality Control (QC) Analytical Laboratory at the Collagen Manufacturing Center (CMC).