CVX-300 EXCIMER LASER VERSION V3.7.12/V3.8.12
FDA premarket approval P960042/S009 · decided 2006-08-02
Approval details
- PMA number
- P960042
- Supplement
- S009
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- CVX-300 EXCIMER LASER VERSION V3.7.12/V3.8.12
- Generic name
- DEVICE, REMOVAL, PACEMAKER ELECTRODE, PERCUTANEOUS
- Applicant
- Spectranetics (Philips)
- Date received
- 2006-04-14
- Decision date
- 2006-08-02
- Days to decision
- 110 days
- Decision code
- APPR
- Product code
- MFA
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Colorado Springs, CO
- Statement
- APPROVAL FOR A NEW SOFTWARE VERSION TO THE CVX-3000 EXCIMER LASER AND REVISED LABELING TO THE LASER CONSOLE.
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