SelectSecure MRI SureScan Lead
FDA premarket approval P030036/S098 · decided 2018-03-01
Approval details
- PMA number
- P030036
- Supplement
- S098
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- SelectSecure MRI SureScan Lead
- Generic name
- Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2017-12-04
- Decision date
- 2018-03-01
- Days to decision
- 87 days
- Decision code
- APPR
- Product code
- NVN
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- Approval for the addition of the Primo MRI SureScan and Mirro MRI SureScan ICDs to the Evera MRI Conditional family of devices.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.