CAPSURE FIX NOVUS MRI SURESCAN LEAD MODELS 5076 AND 4076
FDA premarket approval P930039/S168 · decided 2017-04-25
Approval details
- PMA number
- P930039
- Supplement
- S168
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- CAPSURE FIX NOVUS MRI SURESCAN LEAD MODELS 5076 AND 4076
- Generic name
- Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
- Applicant
- Medtronic, Inc.
- Date received
- 2017-01-25
- Decision date
- 2017-04-25
- Days to decision
- 90 days
- Decision code
- APPR
- Product code
- NVN
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- Approval for 1.5 and 3T MR Conditional labeling for MRI SureScan Lead Model 6946M.
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