MEDTRONIC CAPSURE SP MODEL 4523M
FDA premarket approval P830061/S029 · decided 1998-10-09
Approval details
- PMA number
- P830061
- Supplement
- S029
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- MEDTRONIC CAPSURE SP MODEL 4523M
- Generic name
- permanent pacemaker Electrode
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 1998-09-01
- Decision date
- 1998-10-09
- Days to decision
- 38 days
- Decision code
- APPR
- Product code
- DTB
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- Approval for removing the platinum sputtering from the conductor coil of the device.
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