PMA P830061S209
- Device
- CapSure Sense Lead
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- PMA number
- P830061
- Supplement
- S209
- Product code
- NVN
- Decision date
- 2022-10-25
- Generic name
- Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
- Approval order statement
- Add two ethylene oxide sterilization systems at Medtronics Singapore Operations.
Current openFDA PMA Record#
- Device
- CapSure Sense Lead
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- PMA number
- P830061
- Supplement
- S209
- Product code
- NVN
- Generic name
- Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
- Decision date
- 2022-10-25
- Decision code
- OK30
- Date received
- 2022-10-19
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Add two ethylene oxide sterilization systems at Medtronics Singapore Operations.