PMA P910001S013
- Device
- VITESSE TM -E (ECCENTRIC MONORAIL) CATHETER MODEL 120-008
- Applicant
- Spectranetics Corp.
- PMA number
- P910001
- Supplement
- S013
- Product code
- LPC
- Decision date
- 1999-03-12
- Classification
- Device, Angioplasty, Laser, Coronary
- Generic name
- DEVICE, ANGIOPLASTY, LASER, CORONARY
- Approval order statement
- Approval for Software Versions 3.51 and 3.6.
Current openFDA PMA Record#
- Device
- VITESSE TM -E (ECCENTRIC MONORAIL) CATHETER MODEL 120-008
- Applicant
- Spectranetics Corp.
- PMA number
- P910001
- Supplement
- S013
- Product code
- LPC
- Generic name
- DEVICE, ANGIOPLASTY, LASER, CORONARY
- Decision date
- 1999-03-12
- Decision code
- APPR
- Date received
- 1998-03-17
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for Software Versions 3.51 and 3.6.