CAPSUREFIX MRI SURESCAN LEAD
FDA premarket approval P090013/S245 · decided 2017-05-06
Approval details
- PMA number
- P090013
- Supplement
- S245
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- CAPSUREFIX MRI SURESCAN LEAD
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Applicant
- Medtronic, Inc.
- Date received
- 2016-12-06
- Decision date
- 2017-05-06
- Days to decision
- 151 days
- Decision code
- APPR
- Product code
- LWP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- Approval for the Percepta/Percepta Quad, Serena/Serena Quad and Solara/Solara Quad CRT-P MRI SureScan Implantable Pulse Generators with Cardiac Resynchronization Therapy.
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