SelectSecure Lead
FDA premarket approval P030036/S141 · decided 2022-11-28
Approval details
- PMA number
- P030036
- Supplement
- S141
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- SelectSecure Lead
- Generic name
- Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2022-11-21
- Decision date
- 2022-11-28
- Days to decision
- 7 days
- Decision code
- OK30
- Product code
- NVN
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- Implement a mechanical de-gating fixture and to update in-process inspections at a direct supplier.
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