SPECTRANETICS LASER SHEATH
FDA premarket approval P960042/S008 · decided 2002-05-02
Approval details
- PMA number
- P960042
- Supplement
- S008
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- SPECTRANETICS LASER SHEATH
- Generic name
- DEVICE, REMOVAL, PACEMAKER ELECTRODE, PERCUTANEOUS
- Applicant
- Spectranetics (Philips)
- Date received
- 2002-01-17
- Decision date
- 2002-05-02
- Days to decision
- 105 days
- Decision code
- APPR
- Product code
- MFA
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Colorado Springs, CO
- Statement
- APPROVAL FOR A MODIFICATION TO THE 12F AND 14F LASER SHEATH KITS (MODELS 500-001 AND 500-012).
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