VITESSE TM -E (ECCENTRIC MONORAIL) CATHETER MODEL 120-008
FDA premarket approval P910001/S012 · decided 1997-09-24
Approval details
- PMA number
- P910001
- Supplement
- S012
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- VITESSE TM -E (ECCENTRIC MONORAIL) CATHETER MODEL 120-008
- Generic name
- DEVICE, ANGIOPLASTY, LASER, CORONARY
- Applicant
- Spectranetics Corp.
- Date received
- 1996-11-27
- Decision date
- 1997-09-24
- Days to decision
- 301 days
- Decision code
- APPR
- Product code
- LPC
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Colorado Springs, CO
- Statement
- Approval for the 2.0 mm Vitesse(TM)-EII (Eccentric Monorail) Catheter, Model 120-008.
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