SPECTRANETICS LASER SHEATH DEVICE
FDA premarket approval P960042/S031 · decided 2012-04-20
Approval details
- PMA number
- P960042
- Supplement
- S031
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- SPECTRANETICS LASER SHEATH DEVICE
- Generic name
- DEVICE, REMOVAL, PACEMAKER ELECTRODE, PERCUTANEOUS
- Applicant
- Spectranetics (Philips)
- Date received
- 2011-09-06
- Decision date
- 2012-04-20
- Days to decision
- 227 days
- Decision code
- APPR
- Product code
- MFA
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Colorado Springs, CO
- Statement
- APPROVAL FOR AN INCREASE IN THE MAXIMUM REPETITION RATE FROM 40 HZ TO 80 HZ OF THE SPECTRANETICS LASER SHEATH. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME GLIDELIGHT LASER SHEATH.
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