CapSure Sense Leads
FDA premarket approval P830061/S169 · decided 2019-06-04
Approval details
- PMA number
- P830061
- Supplement
- S169
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- CapSure Sense Leads
- Generic name
- Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2019-05-29
- Decision date
- 2019-06-04
- Days to decision
- 6 days
- Decision code
- OK30
- Product code
- NVN
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- Replace all Calrod Heating Coils and implement single piece thermal shaping tray configuration.
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