14FR. AND 16FR. LASER SHEATH KIT AND FISH TAPE
FDA premarket approval P960042/S003 · decided 1999-02-08
Approval details
- PMA number
- P960042
- Supplement
- S003
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- 14FR. AND 16FR. LASER SHEATH KIT AND FISH TAPE
- Applicant
- Spectranetics (Philips)
- Date received
- 1998-08-14
- Decision date
- 1999-02-08
- Days to decision
- 178 days
- Decision code
- APPR
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Colorado Springs, CO
- Statement
- Approval for separately packaged 12 French Outer Sheaths.
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