- Device
- Tendril SDX, ST, STS and OptiSense LV leads
- Applicant
- ABBOTT MEDICAL
- PMA number
- P960013
- Supplement
- S081
- Product code
- NVN
- Generic name
- Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
- Decision date
- 2016-05-01
- Decision code
- OK30
- Date received
- 2016-04-12
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Alternate analytical testing laboratory and implementation of an identity test for monolithic controlled release devices.