- Device
- Tendril SDX, Tendril ST, Tendril STS and Optisense leads
- Applicant
- ABBOTT MEDICAL
- PMA number
- P960013
- Supplement
- S085
- Product code
- NVN
- Generic name
- Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
- Decision date
- 2017-01-13
- Decision code
- APPR
- Date received
- 2016-09-27
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for changes to the extraction test method for steroid eluting leads.