SPECTRANETICS LASER SHEATH (SLS) CATHETERS
FDA premarket approval P960042/S014 · decided 2009-07-28
Approval details
- PMA number
- P960042
- Supplement
- S014
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- SPECTRANETICS LASER SHEATH (SLS) CATHETERS
- Generic name
- DEVICE, REMOVAL, PACEMAKER ELECTRODE, PERCUTANEOUS
- Applicant
- Spectranetics (Philips)
- Date received
- 2009-06-02
- Decision date
- 2009-07-28
- Days to decision
- 56 days
- Decision code
- APPR
- Product code
- MFA
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Colorado Springs, CO
- Statement
- APPROVAL FOR A CHANGE OF MATERIAL USED TO MAKE THE PROXIMAL COUPLER OF THE CATHETER. THE MATERIAL WILL BE CHANGED FROM DOW MAGNUM 9555 TO SABIC CYCOLAC MG47MD.
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