- Device
- Tendril SDX, OptiSense, Tendril STS, and Tendril ST
- Applicant
- ABBOTT MEDICAL
- PMA number
- P960013
- Supplement
- S111
- Product code
- NVN
- Generic name
- Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
- Decision date
- 2020-03-26
- Decision code
- OK30
- Date received
- 2020-02-27
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Update the dexamethasone and total impurities specification limits for annual stability testing.