PMA P960013S083
- Device
- TENDRIL ST, STS AND OPTISENSE LV LEADS
- Applicant
- ABBOTT MEDICAL
- PMA number
- P960013
- Supplement
- S083
- Product code
- NVN
- Decision date
- 2016-09-26
- Generic name
- Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
- Approval order statement
- Approval for changes to the front seal dimensions of the Tendril ST, STS and OptiSense LV leads.
Current openFDA PMA Record#
- Device
- TENDRIL ST, STS AND OPTISENSE LV LEADS
- Applicant
- ABBOTT MEDICAL
- PMA number
- P960013
- Supplement
- S083
- Product code
- NVN
- Generic name
- Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
- Decision date
- 2016-09-26
- Decision code
- APPR
- Date received
- 2016-06-30
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for changes to the front seal dimensions of the Tendril ST, STS and OptiSense LV leads.