TENDRIL ST, STS AND OPTISENSE LV LEADS
FDA premarket approval P960013/S083 · decided 2016-09-26
Approval details
- PMA number
- P960013
- Supplement
- S083
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- TENDRIL ST, STS AND OPTISENSE LV LEADS
- Generic name
- Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
- Applicant
- ABBOTT MEDICAL
- Date received
- 2016-06-30
- Decision date
- 2016-09-26
- Days to decision
- 88 days
- Decision code
- APPR
- Product code
- NVN
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Sylmar, CA
- Statement
- Approval for changes to the front seal dimensions of the Tendril ST, STS and OptiSense LV leads.
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