| 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 | COBRA PzF NanoCoated Coronary Stent System |
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| Generic Name | STENT, CORONARY |
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| Applicant | CELONOVA BIOSCIENCES, INC.
8023 Vantage Drive, Suite 1500
San Antonio, TX 78230 |
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| PMA Number | P160014 |
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| Date Received | 05/02/2016 |
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| Decision Date | 02/21/2017 |
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|
Withdrawal Date
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12/22/2022 |
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| Product Code |
MAF |
| Docket Number | 17M-1122 |
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| Notice Date | 02/17/2017 |
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| Advisory Committee |
Cardiovascular |
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| Clinical Trials | NCT01925794
|
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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 COBRA PzF NanoCoated Coronary Stent System is indicated for improving coronary luminal diameter in patients, including patients with diabetes mellitus, with symptomatic ischemic heart disease due to do novo lesions in native coronary arteries. The COBRA PzF Stent System is intended for use in patients eligible for percutaneous transluminal coronary angioplasty (PTCA) with a reference vessel diameter of 2.5-4.0 mm and lesion length of <24 mm. |
| Approval Order | Approval Order |
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| 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 |
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