SPECTRANETICS LASER SHEATH
FDA premarket approval P960042/S043 · decided 2013-06-14
Approval details
- PMA number
- P960042
- Supplement
- S043
- 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
- 2012-11-07
- Decision date
- 2013-06-14
- Days to decision
- 219 days
- Decision code
- APPR
- Product code
- MFA
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Colorado Springs, CO
- Statement
- APPROVAL FOR A MATERIAL CHANGE TO THE INNER LINER OF THE DEVICES.
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