PMA P910001S014
- Device
- VITESSE-C OS CATHETER MODELS 114-009, 117-016, AND 120-009
- Applicant
- Spectranetics Corp.
- PMA number
- P910001
- Supplement
- S014
- Product code
- LPC
- Decision date
- 2000-01-28
- Classification
- Device, Angioplasty, Laser, Coronary
- Generic name
- DEVICE, ANGIOPLASTY, LASER, CORONARY
- Approval order statement
- Approval is for the Vitesse-C OS Laser Angioplasty Cathethers, Models 114-009, 117-016, and 120-009.
Current openFDA PMA Record#
- Device
- VITESSE-C OS CATHETER MODELS 114-009, 117-016, AND 120-009
- Applicant
- Spectranetics Corp.
- PMA number
- P910001
- Supplement
- S014
- Product code
- LPC
- Generic name
- DEVICE, ANGIOPLASTY, LASER, CORONARY
- Decision date
- 2000-01-28
- Decision code
- APPR
- Date received
- 1998-08-25
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval is for the Vitesse-C OS Laser Angioplasty Cathethers, Models 114-009, 117-016, and 120-009.