DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM
FDA premarket approval P130005/S013 · decided 2016-06-07
Approval details
- PMA number
- P130005
- Supplement
- S013
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM
- Generic name
- CATHETER, CORONARY, ATHERECTOMY
- Applicant
- Cardiovascular Systems, Inc.
- Date received
- 2016-05-13
- Decision date
- 2016-06-07
- Days to decision
- 25 days
- Decision code
- OK30
- Product code
- MCX
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- Use an alternate supplier for a component used to construct the OAS Pump.
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