PMA P900033S026

Device: INTEGRA ARTIFICIAL SKIN DERMAL REGENERATION TEMPLATE
Applicant: Integra Lifesciences Corp.
PMA number: P900033
Supplement: S026
Product code: MDD
Decision date: 2015-02-05
Classification: Device, Dermal Replacement
Generic name: Device, dermal replacement
Approval order statement: APPROVAL FOR THE FOLLOWING CHANGES:1) CHANGE IN CLEANING DETERGENT FOR CERTAIN EQUIPMENT;2) CHANGE IN CLEANING METHOD FOR CERTAIN EQUIPMENT, UTILIZING ISOPROPYL ALCOHOL;3) ESTABLISHMENT OF EQUIPMENT DIRTY HOLD TIME (DHT); AND 4) ESTABLISHMENT OF A METHOD TO TEST FOR RESIDUES.

Current openFDA PMA Record#

Device: INTEGRA ARTIFICIAL SKIN DERMAL REGENERATION TEMPLATE
Applicant: Integra Lifesciences Corp.
PMA number: P900033
Supplement: S026
Product code: MDD
Generic name: Device, dermal replacement
Decision date: 2015-02-05
Decision code: APPR
Date received: 2013-04-26
Supplement type: 135 Review Track For 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: APPROVAL FOR THE FOLLOWING CHANGES:1) CHANGE IN CLEANING DETERGENT FOR CERTAIN EQUIPMENT;2) CHANGE IN CLEANING METHOD FOR CERTAIN EQUIPMENT, UTILIZING ISOPROPYL ALCOHOL;3) ESTABLISHMENT OF EQUIPMENT DIRTY HOLD TIME (DHT); AND 4) ESTABLISHMENT OF A METHOD TO TEST FOR RESIDUES.