CAPSUREFIX NOVUS MRI SURESCAN LEAD MODEL 5076
FDA premarket approval P930039/S130 · decided 2015-06-22
Approval details
- PMA number
- P930039
- Supplement
- S130
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- CAPSUREFIX NOVUS MRI SURESCAN LEAD MODEL 5076
- Generic name
- Permanent defibrillator electrodes
- Applicant
- Medtronic, Inc.
- Date received
- 2015-04-20
- Decision date
- 2015-06-22
- Days to decision
- 63 days
- Decision code
- APPR
- Product code
- NVY
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- APPROVAL FOR THE USE OF THE CAPSUREFIX NOVUS MRI SURESCAN LEAD MODEL 5076 MRI WITH THE ADVISA SR MRI A3SR01 IMPLANTABLE PULSE GENERATOR.
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