SelectSecure Lead
FDA premarket approval P030036/S140 · decided 2022-11-22
Approval details
- PMA number
- P030036
- Supplement
- S140
- 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
- 2022-11-16
- Decision date
- 2022-11-22
- Days to decision
- 6 days
- Decision code
- OK30
- Product code
- NVN
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- Relocation of the Chemical Operations area within the same manufacturing facility (Medtronic Energy and Component Center) for selected components.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.