PMA P960042S001
- Device
- SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM & LASER SHEATH 12 FRENCH OUTER SHEATH
- Applicant
- Spectranetics (Philips)
- PMA number
- P960042
- Supplement
- S001
- Decision date
- 1998-06-16
- Approval order 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.
Current openFDA PMA Record#
- Device
- SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM & LASER SHEATH 12 FRENCH OUTER SHEATH
- Applicant
- Spectranetics (Philips)
- PMA number
- P960042
- Supplement
- S001
- Decision date
- 1998-06-16
- Decision code
- APPR
- Date received
- 1997-12-12
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order 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.