14 FR. AND 16 FR. LASER SHEATH KIT AND FISH TAPE
FDA premarket approval P960042/S002 · decided 1998-09-04
Approval details
- PMA number
- P960042
- Supplement
- S002
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- 14 FR. AND 16 FR. LASER SHEATH KIT AND FISH TAPE
- Applicant
- Spectranetics (Philips)
- Date received
- 1998-03-09
- Decision date
- 1998-09-04
- Days to decision
- 179 days
- Decision code
- APPR
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Colorado Springs, CO
- Statement
- Approval for the 14 French (Fr.) and 16 Fr. Laser Sheath Kits and individually packaged accessory devices (14 Fr. and 16 Fr. Outer Sheaths and Fish Tape). The Laser Sheath Kits include: one Laser Sheath (14 Fr. or 16 Fr.), two Outer Sheaths (14 Fr. or 16 Fr.), and a Fish Tape. The laser Sheath Kits, as modified, will be marketed under the trade names 14 Fr. and 16 Fr. Laser Sheath Kits and are indicated for use as an adjunct to conventional lead extraction tools in patients suitable for transven
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