PMA P910001S049
- Device
- CVX EXCIMER LASER SYSTEMS
- Applicant
- Spectranetics Corp.
- PMA number
- P910001
- Supplement
- S049
- Product code
- LPC
- Decision date
- 2011-10-25
- Classification
- Device, Angioplasty, Laser, Coronary
- Generic name
- DEVICE, ANGIOPLASTY, LASER, CORONARY
- Approval order statement
- APPROVAL FOR SOFTWARE CHANGES TO THE CVX-300 AND CVX-300-P LASER SYSTEMS.
Current openFDA PMA Record#
- Device
- CVX EXCIMER LASER SYSTEMS
- Applicant
- Spectranetics Corp.
- PMA number
- P910001
- Supplement
- S049
- Product code
- LPC
- Generic name
- DEVICE, ANGIOPLASTY, LASER, CORONARY
- Decision date
- 2011-10-25
- Decision code
- APPR
- Date received
- 2011-08-26
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR SOFTWARE CHANGES TO THE CVX-300 AND CVX-300-P LASER SYSTEMS.