PMA P910001S012
- Device
- VITESSE TM -E (ECCENTRIC MONORAIL) CATHETER MODEL 120-008
- Applicant
- Spectranetics Corp.
- PMA number
- P910001
- Supplement
- S012
- Product code
- LPC
- Decision date
- 1997-09-24
- Classification
- Device, Angioplasty, Laser, Coronary
- Generic name
- DEVICE, ANGIOPLASTY, LASER, CORONARY
- Approval order statement
- Approval for the 2.0 mm Vitesse(TM)-EII (Eccentric Monorail) Catheter, Model 120-008.
Current openFDA PMA Record#
- Device
- VITESSE TM -E (ECCENTRIC MONORAIL) CATHETER MODEL 120-008
- Applicant
- Spectranetics Corp.
- PMA number
- P910001
- Supplement
- S012
- Product code
- LPC
- Generic name
- DEVICE, ANGIOPLASTY, LASER, CORONARY
- Decision date
- 1997-09-24
- Decision code
- APPR
- Date received
- 1996-11-27
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for the 2.0 mm Vitesse(TM)-EII (Eccentric Monorail) Catheter, Model 120-008.