SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM & LASER SHEATH
FDA premarket approval P960042 · decided 1997-12-09
Approval details
- PMA number
- P960042
- Trade name
- SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM & LASER SHEATH
- Generic name
- DEVICE, REMOVAL, PACEMAKER ELECTRODE, PERCUTANEOUS
- Applicant
- Spectranetics (Philips)
- Date received
- 1996-11-26
- Decision date
- 1997-12-09
- Days to decision
- 378 days
- Decision code
- APPR
- Product code
- MFA
- Advisory committee
- Cardiovascular
- Expedited review
- Yes
- Location
- Colorado Springs, CO
- Statement
- Approval for the 12 French Laser Sheath Kit which consists of the 12 French Laser Sheath (Model 500-001) and Fish Tape accessory. The device is indicated for use as an adjunct to conventional lead extraction tools in patients suitable for transvenous removal of chronically implanted pacing or defibrillator leads constructed with silicone or polyurethane outer insulation.
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