PMA P900033S048

Device: INTEGRA DERMAL REGENERATION TEMPLATE
Applicant: Integra Lifesciences Corp.
PMA number: P900033
Supplement: S048
Product code: MDD
Decision date: 2015-06-25
Classification: Device, Dermal Replacement
Generic name: Device, dermal replacement
Approval order statement: QUALIFICATION OF A NEW METHOD FOR QUARTERLY STERILIZATION DOSE AUDITS FOR THE INTEGRA DERMAL REGENERATION TEMPLATE MANUFACTURED AT THE PLAINSBORO, NEW JERSEY, INTEGRA MANUFACTURING FACILITY.

Current openFDA PMA Record#

Device: INTEGRA DERMAL REGENERATION TEMPLATE
Applicant: Integra Lifesciences Corp.
PMA number: P900033
Supplement: S048
Product code: MDD
Generic name: Device, dermal replacement
Decision date: 2015-06-25
Decision code: OK30
Date received: 2015-06-03
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: QUALIFICATION OF A NEW METHOD FOR QUARTERLY STERILIZATION DOSE AUDITS FOR THE INTEGRA DERMAL REGENERATION TEMPLATE MANUFACTURED AT THE PLAINSBORO, NEW JERSEY, INTEGRA MANUFACTURING FACILITY.