PMA P130005S014

Device: DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY DEVICE (OAD), ORBITAL ATHERECTOMY SYSTEM PUMP (OAS PUMP), VIPERWIRE ADVANCE
Applicant: Cardiovascular Systems, Inc.
PMA number: P130005
Supplement: S014
Product code: MCX
Decision date: 2017-03-19
Classification: Catheter, Coronary, Atherectomy
Generic name: CATHETER, CORONARY, ATHERECTOMY
Approval order statement: Approval for a change in the design of the DIAMONDBACK 360 Coronary Orbital Atherectomy System (OAS), called OAS Micro Crown.

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: S014
Product code: MCX
Generic name: CATHETER, CORONARY, ATHERECTOMY
Decision date: 2017-03-19
Decision code: APPR
Date received: 2016-08-11
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: Approval for a change in the design of the DIAMONDBACK 360 Coronary Orbital Atherectomy System (OAS), called OAS Micro Crown.