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Device | SPECTRANETICS LASER SHEATH (SLS) CATHETERS |
Generic Name | DEVICE, REMOVAL, PACEMAKER ELECTRODE, PERCUTANEOUS |
Applicant | Spectranetics (Philips) 9965 Federal Drive Colorado Springs, CO 80921 |
PMA Number | P960042 |
Supplement Number | S014 |
Date Received | 06/02/2009 |
Decision Date | 07/28/2009 |
Product Code |
MFA |
Advisory Committee |
Cardiovascular |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order 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. |