PMA P130005S005

Device: DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM (OAS)
Applicant: Cardiovascular Systems, Inc.
PMA number: P130005
Supplement: S005
Product code: MCX
Decision date: 2015-07-07
Classification: Catheter, Coronary, Atherectomy
Generic name: CATHETER, CORONARY, ATHERECTOMY
Approval order statement: APPROVAL OF CHANGES TO THE STERILIZATION PROCESS, INCLUDING AN ADDITIONAL STERILIZATION CHAMBER, ALTERNATIVE CONFIGURATIONS FOR PROCESS CHALLENGE DEVICES, REDUCTION IN AERATION TIME, AND ADDITIONAL POST-NITROGEN WASHES AND EVACUATIONS.

Current openFDA PMA Record#

Device: DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM (OAS)
Applicant: Cardiovascular Systems, Inc.
PMA number: P130005
Supplement: S005
Product code: MCX
Generic name: CATHETER, CORONARY, ATHERECTOMY
Decision date: 2015-07-07
Decision code: APPR
Date received: 2014-12-18
Supplement type: 135 Review Track For 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: APPROVAL OF CHANGES TO THE STERILIZATION PROCESS, INCLUDING AN ADDITIONAL STERILIZATION CHAMBER, ALTERNATIVE CONFIGURATIONS FOR PROCESS CHALLENGE DEVICES, REDUCTION IN AERATION TIME, AND ADDITIONAL POST-NITROGEN WASHES AND EVACUATIONS.