Tendril MRI Pacing Leads / Assurity MRI, Endurity MRI, Zenex MRI, Zenus MRI Pacemakers
FDA premarket approval P140033/S100 · decided 2025-11-20
Approval details
- PMA number
- P140033
- Supplement
- S100
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- Tendril MRI Pacing Leads / Assurity MRI, Endurity MRI, Zenex MRI, Zenus MRI Pacemakers
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Applicant
- ABBOTT MEDICAL
- Date received
- 2025-09-10
- Decision date
- 2025-11-20
- Days to decision
- 71 days
- Decision code
- APPR
- Product code
- LWP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Sylmar, CA
- Statement
- approval for model line extensions for the Zenex MRI & Zenus MRI families of pacemakers and updated labeling for cardiac leads and additional pacemaker models
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