| Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling. |
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| Device | OPTIMIZER Smart System |
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| Generic Name | Implantable pulse generator |
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| Applicant | Impulse Dynamics (USA), Inc.
50 Lake Center Executive Parkway
401 Route 73N, Bldg. 50 ste 100
Marlton, NJ 08053 |
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| PMA Number | P180036 |
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| Date Received | 09/05/2018 |
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| Decision Date | 03/21/2019 |
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| Product Code |
QFV |
| Docket Number | 19M-1313 |
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| Notice Date | 03/22/2019 |
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| Advisory Committee |
Cardiovascular |
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| Clinical Trials | NCT01381172
|
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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 OPTIMIZER Smart System. The device which delivers Cardiac Contractility Modulation therapy, is indicated to improve 6-minute hall walk distance, quality of life, and functional status of NYHA Class III heart failure patients who remain symptomatic despite guideline directed medical therapy, who are in normal sinus rhythm, are not indicated for Cardiac Resynchronization Therapy, and have a left ventricular ejection fraction ranging from 25% to 45%. |
| Approval Order | Approval Order |
|---|
| Summary | Summary of Safety and Effectiveness |
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| Labeling | Labeling
Labeling Part 2 |
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| Post-Approval Study | Show Report Schedule and Study Progress |
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| Supplements: |
S001 S002 S003 S004 S005 S006 S007 S008 S009 S010 S011
S012 S013 S014 S015 S016 S017 S018 S019 S020 S021 S022 S023
S024 S025 S026 S027 |
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