CapSure Sense Lead
FDA premarket approval P830061/S189 · decided 2020-12-22
Approval details
- PMA number
- P830061
- Supplement
- S189
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- CapSure Sense Lead
- Generic name
- Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2020-12-03
- Decision date
- 2020-12-22
- Days to decision
- 19 days
- Decision code
- APPR
- Product code
- NVN
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- Manufacturing site located at Medtronic Singapore Operations: 49 Changi South Avenue 2, Nasaco Tech Centre, Singapore 486056.
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