PMA P130005S002

Device: DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM (OAS)
Applicant: Cardiovascular Systems, Inc.
PMA number: P130005
Supplement: S002
Product code: MCX
Decision date: 2015-02-12
Classification: Catheter, Coronary, Atherectomy
Generic name: CATHETER, CORONARY, ATHERECTOMY
Approval order statement: APPROVAL FOR CHANGES TO THE DESIGN OF THE ORBITAL ATHERECTOMY SYSTEM PUMP (OAS PUMP MODEL SIP-3000) INCLUDING THE ADDITION OF A SECONDARY MOTOR FEEDBACK PRINTED CIRCUIT BOARD, THE ADDITION OF A SHROUD OVER THE AC POWER CORD CONNECTION, THE ADDITION OF A 100% INSPECTION OF POWER JACK RETENTION, AND THE SELECTION OF AN ALTERNATE VENDOR FOR THE TIMER COMPONENT.

Current openFDA PMA Record#

Device: DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM (OAS)
Applicant: Cardiovascular Systems, Inc.
PMA number: P130005
Supplement: S002
Product code: MCX
Generic name: CATHETER, CORONARY, ATHERECTOMY
Decision date: 2015-02-12
Decision code: APPR
Date received: 2014-08-11
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR CHANGES TO THE DESIGN OF THE ORBITAL ATHERECTOMY SYSTEM PUMP (OAS PUMP MODEL SIP-3000) INCLUDING THE ADDITION OF A SECONDARY MOTOR FEEDBACK PRINTED CIRCUIT BOARD, THE ADDITION OF A SHROUD OVER THE AC POWER CORD CONNECTION, THE ADDITION OF A 100% INSPECTION OF POWER JACK RETENTION, AND THE SELECTION OF AN ALTERNATE VENDOR FOR THE TIMER COMPONENT.