PMA P900033S092

Device: INTEGRA Dermal Regeneration Template, Integra Meshed Dermal Regeneration Template and Integra Omnigraft Dermal Regenerat
Applicant: Integra Lifesciences Corp.
PMA number: P900033
Supplement: S092
Product code: MGR
Decision date: 2021-01-19
Generic name: Dressing, wound and burn, interactive
Approval order statement: Split of an existing Compressed Air Point of Use to support additional packaging capacities at the Integra LifeSciences Corporation, Collagen Manufacturing Center in Plainsboro, New Jersey.

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: S092
Product code: MGR
Generic name: Dressing, wound and burn, interactive
Decision date: 2021-01-19
Decision code: OK30
Date received: 2020-12-23
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Split of an existing Compressed Air Point of Use to support additional packaging capacities at the Integra LifeSciences Corporation, Collagen Manufacturing Center in Plainsboro, New Jersey.