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Device | SPECTRANETICS LASER SHEATH (SLS) II AND GLIDELIGHT LASER SHEATH |
Generic Name | DEVICE, REMOVAL, PACEMAKER ELECTRODE, PERCUTANEOUS |
Applicant | Spectranetics (Philips) 9965 Federal Drive Colorado Springs, CO 80921 |
PMA Number | P960042 |
Supplement Number | S042 |
Date Received | 10/01/2012 |
Decision Date | 10/31/2012 |
Product Code |
MFA |
Advisory Committee |
Cardiovascular |
Supplement Type | Special (Immediate Track) |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR MODIFYING THE SLS II AND GLIDELIGHT INSTRUCTION FOR USE MANUALS TO INCLUDE A WARNING AND PRECAUTION STATEMENT AND STRENGTHEN A WARNING. |