- Device
- CapSure Sense Lead
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- PMA number
- P830061
- Supplement
- S189
- Product code
- NVN
- Generic name
- Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
- Decision date
- 2020-12-22
- Decision code
- APPR
- Date received
- 2020-12-03
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Manufacturing site located at Medtronic Singapore Operations: 49 Changi South Avenue 2, Nasaco Tech Centre, Singapore 486056.