PMA P130005S016

Device: Diamondback 360 Coronary Orbital Atherectomy Device (OAD)
Applicant: Cardiovascular Systems, Inc.
PMA number: P130005
Supplement: S016
Product code: MCX
Decision date: 2017-05-03
Classification: Catheter, Coronary, Atherectomy
Generic name: CATHETER, CORONARY, ATHERECTOMY
Approval order statement: Approval to revert to manufacturing a previously approved design of the saline pump used as part of CSI’s diamondback 360 Orbital Atherectomy System.

Current openFDA PMA Record#

Device: Diamondback 360 Coronary Orbital Atherectomy Device (OAD)
Applicant: Cardiovascular Systems, Inc.
PMA number: P130005
Supplement: S016
Product code: MCX
Generic name: CATHETER, CORONARY, ATHERECTOMY
Decision date: 2017-05-03
Decision code: APPR
Date received: 2017-03-02
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: Approval to revert to manufacturing a previously approved design of the saline pump used as part of CSI’s diamondback 360 Orbital Atherectomy System.