DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM
FDA premarket approval P130005/S007 · decided 2015-11-30
Approval details
- PMA number
- P130005
- Supplement
- S007
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM
- Generic name
- CATHETER, CORONARY, ATHERECTOMY
- Applicant
- Cardiovascular Systems, Inc.
- Date received
- 2015-02-18
- Decision date
- 2015-11-30
- Days to decision
- 285 days
- Decision code
- APPR
- Product code
- MCX
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- APPROVAL FOR A MANUFACTURING SITE LOCATED AT CARDIOVASCULAR SYSTEMS INC., IN ST. PAUL, MINNESOTA.
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