SelectSecure MRI SureScan Lead
FDA premarket approval P030036/S095 · decided 2017-08-16
Approval details
- PMA number
- P030036
- Supplement
- S095
- Supplement type
- Normal 180 Day Track
- 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
- 2017-05-18
- Decision date
- 2017-08-16
- Days to decision
- 90 days
- Decision code
- APPR
- Product code
- NVN
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- Approval for the Azure SR and DR MRI SureScan Implantable Pulse Generators.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.