Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
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Device | LIVIAN CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATORS (CRT-D) MODELS H220, H225, H227, AND H229 |
Generic Name | Implantable pulse generator, pacemaker (non-CRT) |
Applicant | Boston Scientific Corp. 4100 HAMLINE AVE NORTH ST. PAUL, MN 55112 |
PMA Number | P010012 |
Supplement Number | S176 |
Date Received | 03/12/2008 |
Decision Date | 04/17/2008 |
Product Code |
LWP |
Advisory Committee |
Cardiovascular |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Recalls | CDRH Recalls |
Approval Order Statement APPROVAL FOR AN UPDATED HEADER CONFIGURATION FOR THE CONFIENT AND LIVIAN DEVICE FAMILIES TO INCLUDE CHANGED SETSCREWS, SEAL PLUGS, AND LEFT VENTRICULAR RING LEAD WIRE ROUTING (LIVIAN ONLY) AS WELL AS THE ADDITION OF A NEW MODEL TORQUE WRENCH. |
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