DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM
FDA premarket approval P130005 · decided 2013-10-21
Approval details
- PMA number
- P130005
- Trade name
- DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM
- Generic name
- CATHETER, CORONARY, ATHERECTOMY
- Applicant
- Cardiovascular Systems, Inc.
- Date received
- 2013-03-15
- Decision date
- 2013-10-21
- Days to decision
- 220 days
- Decision code
- APPR
- Product code
- MCX
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- APPROVAL FOR THE DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM (OAS). THE DEVICE IS INDICATED TO FACILITATE STENT DELIVERY IN PATIENTS WITH CORONARY ARTERY DISEASE (CAD) WHO ARE ACCEPTABLE CANDIDATES FOR PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) OR STENTING DUE TO DE NOVO, SEVERELY CALCIFIED CORONARY ARTERY LESIONS.
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