PMA P910001S032
- Device
- CVX-3000 EXCIMER LASER CORONARY ATHRECTOMY (ELCA) SYSTEM
- Applicant
- Spectranetics Corp.
- PMA number
- P910001
- Supplement
- S032
- Product code
- LPC
- Decision date
- 2009-07-29
- Classification
- Device, Angioplasty, Laser, Coronary
- Generic name
- DEVICE, ANGIOPLASTY, LASER, CORONARY
- Approval order statement
- APPROVAL FOR A CHANGE IN THE MATERIAL OF THE PROXIMAL COUPLER COMPONENT OF THE ELCA CATHETERS.
Current openFDA PMA Record#
- Device
- CVX-3000 EXCIMER LASER CORONARY ATHRECTOMY (ELCA) SYSTEM
- Applicant
- Spectranetics Corp.
- PMA number
- P910001
- Supplement
- S032
- Product code
- LPC
- Generic name
- DEVICE, ANGIOPLASTY, LASER, CORONARY
- Decision date
- 2009-07-29
- Decision code
- APPR
- Date received
- 2009-06-02
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR A CHANGE IN THE MATERIAL OF THE PROXIMAL COUPLER COMPONENT OF THE ELCA CATHETERS.