PMA P130005S010

Device: DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY DEVICE (OAD), ORBITAL ATHERECTOMY SYSTEM PUMP (OAS PUMP), VIPERWIRE ADVANCE
Applicant: Cardiovascular Systems, Inc.
PMA number: P130005
Supplement: S010
Product code: MCX
Decision date: 2016-01-21
Classification: Catheter, Coronary, Atherectomy
Generic name: CATHETER, CORONARY, ATHERECTOMY
Approval order statement: A MANUFACTURING PROCESS CHANGE TO THE JOINING OF THE CROWN TO THE DRIVESHAFT OF THE OAS.

Current openFDA PMA Record#

Device: DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY DEVICE (OAD), ORBITAL ATHERECTOMY SYSTEM PUMP (OAS PUMP), VIPERWIRE ADVANCE
Applicant: Cardiovascular Systems, Inc.
PMA number: P130005
Supplement: S010
Product code: MCX
Generic name: CATHETER, CORONARY, ATHERECTOMY
Decision date: 2016-01-21
Decision code: OK30
Date received: 2015-12-23
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: A MANUFACTURING PROCESS CHANGE TO THE JOINING OF THE CROWN TO THE DRIVESHAFT OF THE OAS.