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Device | SPECTRANETICS LASER CATHETERS SLS II LASER SHEATH |
Generic Name | DEVICE, REMOVAL, PACEMAKER ELECTRODE, PERCUTANEOUS |
Applicant | Spectranetics (Philips) 9965 Federal Drive Colorado Springs, CO 80921 |
PMA Number | P960042 |
Supplement Number | S027 |
Date Received | 02/04/2011 |
Decision Date | 07/14/2011 |
Product Code |
MFA |
Advisory Committee |
Cardiovascular |
Supplement Type | 135 Review Track For 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR CHANGES TO PYROGEN TESTING PROCEDURES AND SAMPLING. |