Premarket Approval (PMA)

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.

• Device: PRECISE PRO RX Transcarotid Stent System
• Generic Name: Stent, carotid
• Applicant: Cordis US Corporation; 14201 NW 60th Ave.; Miami Lakes, FL 33014
• PMA Number: P030047
• Supplement Number: S049
• Date Received: 10/01/2024
• Decision Date: 04/04/2025
• Product Code: NIM
• Advisory Committee: Cardiovascular
• Supplement Type: Panel Track
• Supplement Reason: Change Design/Components/Specifications/Material
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No

Approval Order Statement  
The PRECISE® PRO Transcarotid Stent System used in conjunction with the ENROUTE® Transcarotid Neuroprotection System (NPS), is indicated for the treatment of patients at high risk for adverse events from carotid endarterectomy who require carotid revascularization and meet the criteria outlined below.1. Patients with neurological symptoms and >= 50% stenosis of the common or internal carotid artery by ultrasound or angiogram OR patients without neurological symptoms and >= 80% stenosis of the common or internal carotid artery by ultrasound or angiogram, AND2. Patients must have a vessel diameter of 4-9 mm at the target lesion,AND 3. Carotid bifurcation is located at minimum 5cm above the clavicle to allow for placement of the ENROUTE Transcarotid NPS.

• Approval Order: Approval Order
• Summary: Summary of Safety and Effectiveness
• Labeling: Labeling; Labeling Part 2