PMA P910001S091
- Device
- Spectranetics CVX-300 Exclimer Laser System
- Applicant
- Spectranetics Corp.
- PMA number
- P910001
- Supplement
- S091
- Product code
- LPC
- Decision date
- 2017-07-07
- Classification
- Device, Angioplasty, Laser, Coronary
- Generic name
- DEVICE, ANGIOPLASTY, LASER, CORONARY
- Approval order statement
- Approval for changes to the Remote Interlock Connector.
Current openFDA PMA Record#
- Device
- Spectranetics CVX-300 Exclimer Laser System
- Applicant
- Spectranetics Corp.
- PMA number
- P910001
- Supplement
- S091
- Product code
- LPC
- Generic name
- DEVICE, ANGIOPLASTY, LASER, CORONARY
- Decision date
- 2017-07-07
- Decision code
- APPR
- Date received
- 2017-03-09
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for changes to the Remote Interlock Connector.