PMA P960042S009
- Device
- CVX-300 EXCIMER LASER VERSION V3.7.12/V3.8.12
- Applicant
- Spectranetics (Philips)
- PMA number
- P960042
- Supplement
- S009
- Product code
- MFA
- Decision date
- 2006-08-02
- Classification
- Device, Removal, Pacemaker Electrode, Percutaneous
- Generic name
- DEVICE, REMOVAL, PACEMAKER ELECTRODE, PERCUTANEOUS
- Approval order statement
- APPROVAL FOR A NEW SOFTWARE VERSION TO THE CVX-3000 EXCIMER LASER AND REVISED LABELING TO THE LASER CONSOLE.
Current openFDA PMA Record#
- Device
- CVX-300 EXCIMER LASER VERSION V3.7.12/V3.8.12
- Applicant
- Spectranetics (Philips)
- PMA number
- P960042
- Supplement
- S009
- Product code
- MFA
- Generic name
- DEVICE, REMOVAL, PACEMAKER ELECTRODE, PERCUTANEOUS
- Decision date
- 2006-08-02
- Decision code
- APPR
- Date received
- 2006-04-14
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR A NEW SOFTWARE VERSION TO THE CVX-3000 EXCIMER LASER AND REVISED LABELING TO THE LASER CONSOLE.