Patient Cable
FDA premarket approval P820003/S141 · decided 2023-12-15
Approval details
- PMA number
- P820003
- Supplement
- S141
- Supplement type
- Real-Time Process
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Patient Cable
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2023-09-28
- Decision date
- 2023-12-15
- Days to decision
- 78 days
- Decision code
- APPR
- Product code
- LWP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- Approval for packaging and sterilization changes for the Disposable Safety Patient Cables Models 5846A, 5846AL, 5846V, and 5846VL.
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