DIAMONDBACK 360 CONONARY ORBITAL ATHERECTOMY SYSTEM
FDA premarket approval P130005/S001 · decided 2014-10-29
Approval details
- PMA number
- P130005
- Supplement
- S001
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- DIAMONDBACK 360 CONONARY ORBITAL ATHERECTOMY SYSTEM
- Generic name
- CATHETER, CORONARY, ATHERECTOMY
- Applicant
- Cardiovascular Systems, Inc.
- Date received
- 2014-07-28
- Decision date
- 2014-10-29
- Days to decision
- 93 days
- Decision code
- APPR
- Product code
- MCX
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- APPROVAL FOR CHANGES TO THE INSTRUCTIONS FOR USE TO ENHANCE THE SAFETY OF THE DEVICE OR USE OF THE DEVICE.
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