DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM
FDA premarket approval P130005/S012 · decided 2016-10-26
Approval details
- PMA number
- P130005
- Supplement
- S012
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM
- Generic name
- CATHETER, CORONARY, ATHERECTOMY
- Applicant
- Cardiovascular Systems, Inc.
- Date received
- 2016-03-23
- Decision date
- 2016-10-26
- Days to decision
- 217 days
- Decision code
- APPR
- Product code
- MCX
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- Approval to add heat/light stabilizers to the PEBAX used to construct the Saline Sheaths of the OAD.
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