PMA P900033S085

Device: Integra Dermal Regeneration Template, Integra Meshed Dermal Regeneration Template and Integra Omnigraft Dermal Regenerat
Applicant: Integra Lifesciences Corp.
PMA number: P900033
Supplement: S085
Product code: MGR
Decision date: 2019-08-28
Classification: Dressing, Wound And Burn, Interactive
Generic name: Dressing, wound and burn, interactive
Approval order statement: Implement a change of designation of meshed collagen product as master product and alignment of MIDRT bioburden specification with other members in the same sterilization product family

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: S085
Product code: MGR
Generic name: Dressing, wound and burn, interactive
Decision date: 2019-08-28
Decision code: OK30
Date received: 2019-07-31
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Implement a change of designation of meshed collagen product as master product and alignment of MIDRT bioburden specification with other members in the same sterilization product family