SPECTRANETICS LASER SHEATH KITS, 14FR AND 16FR
FDA premarket approval P960042/S004 · decided 1999-08-03
Approval details
- PMA number
- P960042
- Supplement
- S004
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- SPECTRANETICS LASER SHEATH KITS, 14FR AND 16FR
- Applicant
- Spectranetics (Philips)
- Date received
- 1999-02-17
- Decision date
- 1999-08-03
- Days to decision
- 167 days
- Decision code
- APPR
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Colorado Springs, CO
- Statement
- Approval for a 2-year shelf life for the 14 Fr and 16 Fr Laser Sheath Kits.
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