CapSureFix Novus MRI SureScan Lead
FDA premarket approval P930039/S197 · decided 2019-05-30
Approval details
- PMA number
- P930039
- Supplement
- S197
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - PAS
- Trade name
- CapSureFix Novus MRI SureScan Lead
- Generic name
- Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
- Applicant
- Medtronic, Inc.
- Date received
- 2019-05-02
- Decision date
- 2019-05-30
- Days to decision
- 28 days
- Decision code
- APPR
- Product code
- NVN
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
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