MODEL 5024 TRANSVENOUS PACING LEAD
FDA premarket approval P850089/S013 · decided 1990-09-27
Approval details
- PMA number
- P850089
- Supplement
- S013
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- MODEL 5024 TRANSVENOUS PACING LEAD
- Generic name
- permanent pacemaker Electrode
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 1990-04-18
- Decision date
- 1990-09-27
- Days to decision
- 162 days
- Decision code
- APPR
- Product code
- DTB
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
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