PMA P910001S056
- Device
- SPECTRANETICS EXCIMER LASER
- Applicant
- Spectranetics Corp.
- PMA number
- P910001
- Supplement
- S056
- Product code
- LPC
- Decision date
- 2012-07-03
- Classification
- Device, Angioplasty, Laser, Coronary
- Generic name
- DEVICE, ANGIOPLASTY, LASER, CORONARY
- Approval order statement
- APPROVAL FOR A CHANGE TO THE RADIO FREQUENCY (RF) ABSORPTION MATERIAL FOR THE CVX-300P MODEL EXCIMER LASER.
Current openFDA PMA Record#
- Device
- SPECTRANETICS EXCIMER LASER
- Applicant
- Spectranetics Corp.
- PMA number
- P910001
- Supplement
- S056
- Product code
- LPC
- Generic name
- DEVICE, ANGIOPLASTY, LASER, CORONARY
- Decision date
- 2012-07-03
- Decision code
- APPR
- Date received
- 2012-05-08
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR A CHANGE TO THE RADIO FREQUENCY (RF) ABSORPTION MATERIAL FOR THE CVX-300P MODEL EXCIMER LASER.