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Device | SLENDER Sirolimus-Eluting Coronary Stent Integrated Delivery System and DIRECT Sirolimus-Eluting Coronary Stent Rapid Ex |
Generic Name | Coronary drug-eluting stent |
Applicant | Hemoteq AG Adenauerstrasse 15 Würselen 52146 |
PMA Number | P210014 |
Date Received | 04/01/2021 |
Decision Date | 12/13/2021 |
Withdrawal Date
|
03/14/2023 |
Product Code |
NIQ |
Docket Number | 21M-1321 |
Notice Date | 12/16/2021 |
Advisory Committee |
Cardiovascular |
Clinical Trials | NCT01788150
|
Expedited Review Granted? | No |
Combination Product | Yes |
Approval Order Statement Approval for the SLENDER Sirolimus-Eluting Coronary Stent Integrated Delivery System. The device is indicated for improving coronary artery luminal diameter in patients with symptomatic heart disease due to atherosclerotic lesions <= 24 mm in length in native coronary arteries with >= 2.25 mm to <= 4.00 mm reference vessel diameters, using direct stenting or pre-dilatation interventional techniques. DIRECT Sirolimus-Eluting Coronary Stent Rapid Exchange Delivery System is indicated for improving coronary artery luminal diameter in patients with symptomatic heart disease due to atherosclerotic lesions <= 34 mm in length in native coronary arteries with >= 2.25 mm to <= 4.00 mm reference vessel diameters, using direct stenting or pre-dilatation interventional techniques. |
Approval Order | Approval Order |
Summary | Summary of Safety and Effectiveness |
Labeling | Labeling
|
Post-Approval Study | Show Report Schedule and Study Progress |
Supplements: |
S001 S002 |