Medtronic SelectSecure Lead Model 3830
FDA premarket approval P030036/S147 · decided 2024-08-28
Approval details
- PMA number
- P030036
- Supplement
- S147
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Medtronic SelectSecure Lead Model 3830
- Generic name
- Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2024-08-20
- Decision date
- 2024-08-28
- Days to decision
- 8 days
- Decision code
- OK30
- Product code
- NVN
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- implement an additional grind machine, new grind fixture, and automate the helix deburring operation
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.