SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM & LASER SHEATH 12 FRENCH OUTER SHEATH
FDA premarket approval P960042/S001 · decided 1998-06-16
Approval details
- PMA number
- P960042
- Supplement
- S001
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM & LASER SHEATH 12 FRENCH OUTER SHEATH
- Applicant
- Spectranetics (Philips)
- Date received
- 1997-12-12
- Decision date
- 1998-06-16
- Days to decision
- 186 days
- Decision code
- APPR
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Colorado Springs, CO
- Statement
- Approval for the 12 French Outer Sheath. The device is an accessory to the 12 French Laser Sheath and will be packaged in the 12 French Laser Sheath Kit.
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