DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM (OAS)
FDA premarket approval P130005/S002 · decided 2015-02-12
Approval details
- PMA number
- P130005
- Supplement
- S002
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM (OAS)
- Generic name
- CATHETER, CORONARY, ATHERECTOMY
- Applicant
- Cardiovascular Systems, Inc.
- Date received
- 2014-08-11
- Decision date
- 2015-02-12
- Days to decision
- 185 days
- Decision code
- APPR
- Product code
- MCX
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Minneapolis, MN
- 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.
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