Tendril STS 2088TC, OptiSense Low Voltage Pacing Leads
FDA premarket approval P960013/S122 · decided 2023-05-11
Approval details
- PMA number
- P960013
- Supplement
- S122
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Tendril STS 2088TC, OptiSense Low Voltage Pacing Leads
- Generic name
- Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
- Applicant
- ABBOTT MEDICAL
- Date received
- 2022-09-30
- Decision date
- 2023-05-11
- Days to decision
- 223 days
- Decision code
- APPR
- Product code
- NVN
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Sylmar, CA
- Statement
- Approval for the UltiPace Model LPA1231 pacing lead, which incorporates several design and manufacturing modifications to the existing Tendril STS 2088TC lead on the proximal end of the lead.
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