- Device
- Tendril SDX Lead, Tendril ST Lead, OptiSense, Tendril STS Lead, Tendril STS Lead (MR Conditional)
- Applicant
- ABBOTT MEDICAL
- PMA number
- P960013
- Supplement
- S119
- Product code
- NVN
- Generic name
- Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
- Decision date
- 2021-07-07
- Decision code
- OK30
- Date received
- 2021-06-28
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Adjust Bioburden action limit and alert levels at the Sylmar manufacturing site.