PMA P900033S077

Device: Integra Dermal Regeneration Template, Integra Meshed Dermal Regeneration Template and Integra Omnigraft Dermal Regenerat
Applicant: Integra Lifesciences Corp.
PMA number: P900033
Supplement: S077
Product code: MGR
Decision date: 2019-04-19
Classification: Dressing, Wound And Burn, Interactive
Generic name: Dressing, wound and burn, interactive
Approval order statement: Implementation of data integrity and security controls for the Quality Control (QC) Analytical Laboratory Instruments 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: S077
Product code: MGR
Generic name: Dressing, wound and burn, interactive
Decision date: 2019-04-19
Decision code: OK30
Date received: 2019-03-21
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Implementation of data integrity and security controls for the Quality Control (QC) Analytical Laboratory Instruments at the Collagen Manufacturing Center (CMC).