PMA P900033S035

Device: INTEGRA ARTIFICIAL SKIN DERMAL REGENERATION TEMPLATE
Applicant: Integra Lifesciences Corp.
PMA number: P900033
Supplement: S035
Product code: MDD
Decision date: 2014-10-17
Classification: Device, Dermal Replacement
Generic name: Device, dermal replacement
Approval order statement: APPROVAL FOR THE IMPLEMENTATION OF MECHANICAL, PROGRAM, AND SYSTEM CONTROL CHANGES TO THE EXISTING CHILLED WATER SYSTEM THAT SERVICES COLLAGEN LYOPHILIZER MACHINES IN THE LYO MANUFACTURING AREA OF BUILDING 1 AT THE INTEGRA NEUROSCIENCES FACILITY IN AÑASCO, PUERTO RICO, FOR THE DEVICES.

Current openFDA PMA Record#

Device: INTEGRA ARTIFICIAL SKIN DERMAL REGENERATION TEMPLATE
Applicant: Integra Lifesciences Corp.
PMA number: P900033
Supplement: S035
Product code: MDD
Generic name: Device, dermal replacement
Decision date: 2014-10-17
Decision code: APPR
Date received: 2014-04-11
Supplement type: 135 Review Track For 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: APPROVAL FOR THE IMPLEMENTATION OF MECHANICAL, PROGRAM, AND SYSTEM CONTROL CHANGES TO THE EXISTING CHILLED WATER SYSTEM THAT SERVICES COLLAGEN LYOPHILIZER MACHINES IN THE LYO MANUFACTURING AREA OF BUILDING 1 AT THE INTEGRA NEUROSCIENCES FACILITY IN AÑASCO, PUERTO RICO, FOR THE DEVICES.