| Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device. |
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| Trade Name | BAROSTIM NEO LEGACY IMPLANTABLE PULSE GENERATOR (IPG), PROGRAMMER SYSTEM,CAROTID SINUS LEAD (CSL) REPAIR KIT,EXTERNAL IN |
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| Classification Name | stimulator, carotid sinus nerve |
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| Generic Name | stimulator, carotid sinus nerve |
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| Regulation Number | 870.3850 |
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| Applicant |
| CVRx, INC. |
| 9201 west broadway avenue |
| suite 650 |
| minneapolis, MN 55445 |
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| HDE Number | H130007 |
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| Date Received | 12/26/2013 |
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| Decision Date | 12/12/2014 |
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| Product Code | |
| Docket Number | 14M-2247 |
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| Notice Date | 04/17/2015 |
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| Advisory Committee |
Cardiovascular |
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| Clinical Trials |
NCT00442286
NCT01077180
|
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| Supplement Type | hde original |
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| Expedited Review Granted? | No |
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| Combination Product | No |
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Approval Order Statement
Approval for the barostim neo® legacy system. This device is indicated for use in patients with resistant hypertension who have had bilateral implantation of the rheos® carotid sinus leads models 1010r, 1010l, 1014l, and 1014r (which have been discontinued and are obsolete) and were determined responders in the rheos® pivotal clinical study. |
| Approval Order |
Approval Order
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| Summary |
Summary of Safety and Probable Benefit
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| Labeling |
Labeling
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| Supplements: |
S001 S002 S003 S004 S005 |
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