Epsila EV Transverse Tunneling Tool
FDA premarket approval P220012/S044 · decided 2025-05-15
Approval details
- PMA number
- P220012
- Supplement
- S044
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Epsila EV Transverse Tunneling Tool
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Medtronic, Inc.
- Date received
- 2025-02-13
- Decision date
- 2025-05-15
- Days to decision
- 91 days
- Decision code
- APPR
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- approval for minor changes to the Design Specifications of the Epsila EV-ICD Transverse Tunneling Tool (EAZ201)
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