PMA P900033S079

Device: Integra Dermal Regeneration Template, Intergra Meshed Dermal Regeneration Template, and Integra Omnigraft Dermal Regener
Applicant: Integra Lifesciences Corp.
PMA number: P900033
Supplement: S079
Product code: MGR
Decision date: 2019-05-07
Classification: Dressing, Wound And Burn, Interactive
Generic name: Dressing, wound and burn, interactive
Approval order statement: Delete select surface contact sites from Routine Environmental Monitoring for the following rooms: CMC-105 and CMC-109 at the Integra LifeSciences Corporation, Collagen Manufacturing Center in Plainsboro, New Jersey.

Current openFDA PMA Record#

Device: Integra Dermal Regeneration Template, Intergra Meshed Dermal Regeneration Template, and Integra Omnigraft Dermal Regener
Applicant: Integra Lifesciences Corp.
PMA number: P900033
Supplement: S079
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: Delete select surface contact sites from Routine Environmental Monitoring for the following rooms: CMC-105 and CMC-109 at the Integra LifeSciences Corporation, Collagen Manufacturing Center in Plainsboro, New Jersey.