PMA P900033S054

Device: INTEGRA DERMAL REGENERATION TEMPLATE - TERMINALLY STERILIZED
Applicant: Integra Lifesciences Corp.
PMA number: P900033
Supplement: S054
Product code: MDD
Decision date: 2016-05-03
Classification: Device, Dermal Replacement
Generic name: Device, dermal replacement
Approval order statement: Approval for a manufacturing site located at Integra LifeSciences Corporation, 109 Morgan Lane, Plainsboro, New Jersey, as a new and alternate manufacturing facility.

Current openFDA PMA Record#

Device: INTEGRA DERMAL REGENERATION TEMPLATE - TERMINALLY STERILIZED
Applicant: Integra Lifesciences Corp.
PMA number: P900033
Supplement: S054
Product code: MDD
Generic name: Device, dermal replacement
Decision date: 2016-05-03
Decision code: APPR
Date received: 2015-11-24
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Location Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Approval for a manufacturing site located at Integra LifeSciences Corporation, 109 Morgan Lane, Plainsboro, New Jersey, as a new and alternate manufacturing facility.