PMA P900033S071

Device: Integra Dermal Regeneration Template, Integra Meshed Dermal Regeneration Template and Integra Omnigraft Dermal Regenerat
Applicant: Integra Lifesciences Corp.
PMA number: P900033
Supplement: S071
Product code: MGR
Decision date: 2018-07-19
Classification: Dressing, Wound And Burn, Interactive
Generic name: Dressing, wound and burn, interactive
Approval order statement: Change to the site that will conduct the E-Beam dose verification audits for the Collagen Glycosaminonglycan (GAG) Matrix and Omnigraft sterilization product families.

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: S071
Product code: MGR
Generic name: Dressing, wound and burn, interactive
Decision date: 2018-07-19
Decision code: OK30
Date received: 2018-06-20
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Change to the site that will conduct the E-Beam dose verification audits for the Collagen Glycosaminonglycan (GAG) Matrix and Omnigraft sterilization product families.