PMA P900033S043

Device: INTEGRA ARTIFICIAL SKIN DERMAL REGENERATION TEMPLATE
Applicant: Integra Lifesciences Corp.
PMA number: P900033
Supplement: S043
Product code: MDD
Decision date: 2015-03-04
Classification: Device, Dermal Replacement
Generic name: Device, dermal replacement
Approval order statement: QUALIFICATION OF A NEW PRODUCT PACKAGE SEALING EQUIPMENT FOR THE INTEGRA DERMAL REGENERATION TEMPLATE, AT THE PLAINSBORO, NEW JERSEY, INTEGRA MANUFACTURING FACILITY.

Current openFDA PMA Record#

Device: INTEGRA ARTIFICIAL SKIN DERMAL REGENERATION TEMPLATE
Applicant: Integra Lifesciences Corp.
PMA number: P900033
Supplement: S043
Product code: MDD
Generic name: Device, dermal replacement
Decision date: 2015-03-04
Decision code: OK30
Date received: 2015-02-03
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: QUALIFICATION OF A NEW PRODUCT PACKAGE SEALING EQUIPMENT FOR THE INTEGRA DERMAL REGENERATION TEMPLATE, AT THE PLAINSBORO, NEW JERSEY, INTEGRA MANUFACTURING FACILITY.