PMA P900033S027

Device: INTEGRA DERMAL REGENERATION TEMPLATE
Applicant: Integra Lifesciences Corp.
PMA number: P900033
Supplement: S027
Product code: MDD
Decision date: 2013-11-29
Classification: Device, Dermal Replacement
Generic name: Device, dermal replacement
Approval order statement: APPROVAL FOR THE FOLLOWING PROPOSED CHANGES: 1) CHANGE IN CLEANING DETERGENTS; 2) ESTABLISHMENT OF EQUIPMENT DIRTY HOLD TIMES (DHT); AND 3) PROPOSED USE OF TOTAL ORGANIC CARBONS (TOCS) AS A METHOD TO TEST FOR RESIDUES.

Current openFDA PMA Record#

Device: INTEGRA DERMAL REGENERATION TEMPLATE
Applicant: Integra Lifesciences Corp.
PMA number: P900033
Supplement: S027
Product code: MDD
Generic name: Device, dermal replacement
Decision date: 2013-11-29
Decision code: APPR
Date received: 2013-05-01
Supplement type: 135 Review Track For 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: APPROVAL FOR THE FOLLOWING PROPOSED CHANGES: 1) CHANGE IN CLEANING DETERGENTS; 2) ESTABLISHMENT OF EQUIPMENT DIRTY HOLD TIMES (DHT); AND 3) PROPOSED USE OF TOTAL ORGANIC CARBONS (TOCS) AS A METHOD TO TEST FOR RESIDUES.