DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM
FDA premarket approval P130005/S003 · decided 2014-09-26
Approval details
- PMA number
- P130005
- Supplement
- S003
- 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
- 2014-09-02
- Decision date
- 2014-09-26
- Days to decision
- 24 days
- Decision code
- OK30
- Product code
- MCX
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- CHANGE TO THE INCOMING QUALITY CONTROL INSPECTION FOR THE SALINE SHEATH ON THE ORBITAL ATHERECTOMY DEVICE (OAD).
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.