SelectSecure MRI SureScan Lead
FDA premarket approval P030036/S113 · decided 2019-09-20
Approval details
- PMA number
- P030036
- Supplement
- S113
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- 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
- 2019-08-22
- Decision date
- 2019-09-20
- Days to decision
- 29 days
- Decision code
- OK30
- Product code
- NVN
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- Updates to assay and content uniformity acceptance criteria.
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