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 | ACUITY SPIRAL HEART FAILURE LEAD MODELS, 4591, 4592 AND 4593 |
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 | S160 |
Date Received | 10/09/2007 |
Decision Date | 05/16/2008 |
Product Code |
LWP |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track |
Expedited Review Granted? | No |
Combination Product | Yes |
Recalls | CDRH Recalls |
Approval Order Statement APPROVAL FOR THE ACUITY SPIRAL LEAD MODEL 4591, 4592, AND 4593. THE DEVICE IS INDICATED FOR CHRONIC, LEFT-VENTRICULAR PACING AND SENSING VIA THE CORONARY VEINS WHEN USED IN CONJUNCTION WITH A COMPATIBLE PULSE GENERATOR. |
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