PRECISE PRO RX Transcarotid Stent System
FDA premarket approval P030047/S049 · decided 2025-04-04
Approval details
- PMA number
- P030047
- Supplement
- S049
- Supplement type
- Panel Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- PRECISE PRO RX Transcarotid Stent System
- Generic name
- Stent, carotid
- Applicant
- Cordis US Corporation
- Date received
- 2024-10-01
- Decision date
- 2025-04-04
- Days to decision
- 185 days
- Decision code
- APPR
- Product code
- NIM
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Miami Lakes, FL
- 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 co
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