CAPSUREFIX NOVUS MRI SURESCAN LEAD MODEL 5076
FDA premarket approval P930039/S142 · decided 2016-04-28
Approval details
- PMA number
- P930039
- Supplement
- S142
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- CAPSUREFIX NOVUS MRI SURESCAN LEAD MODEL 5076
- Generic name
- Permanent defibrillator electrodes
- Applicant
- Medtronic, Inc.
- Date received
- 2015-10-13
- Decision date
- 2016-04-28
- Days to decision
- 198 days
- Decision code
- APPR
- Product code
- NVY
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- Approval for the expansion of MRI conditional labeling for the Advisa and Evera SureScan systems to 3T MRI.
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