- Device
- TENDRIL SDX, TENDRIL ST, TENDRIL STS AND OPTISENSE LEADS (LV ACTIVE)
- Applicant
- ABBOTT MEDICAL
- PMA number
- P960013
- Supplement
- S087
- Product code
- NVN
- Generic name
- Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
- Decision date
- 2017-01-08
- Decision code
- OK30
- Date received
- 2016-12-13
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Addition of an alternate vendor to supply Polyhexamethylene Oxide used in the manufacturing of Optim.