Patient Cable and Surgical Cable
FDA premarket approval P820003/S138 · decided 2021-01-21
Approval details
- PMA number
- P820003
- Supplement
- S138
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Patient Cable and Surgical Cable
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2020-11-05
- Decision date
- 2021-01-21
- Days to decision
- 77 days
- Decision code
- APPR
- Product code
- LWP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- Approval for a labeling update for the affected reusable cable products.
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