TENDRIL STS LEAD MODEL 2088TC
FDA premarket approval P960013/S046 · decided 2009-05-26
Approval details
- PMA number
- P960013
- Supplement
- S046
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- TENDRIL STS LEAD MODEL 2088TC
- Generic name
- Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
- Applicant
- ABBOTT MEDICAL
- Date received
- 2009-03-31
- Decision date
- 2009-05-26
- Days to decision
- 56 days
- Decision code
- APPR
- Product code
- NVN
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Sylmar, CA
- Statement
- APPROVAL FOR DISTAL TIP CHANGES TO THE TENDRIL ST MODEL 1888 LEAD FAMILY. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME TENDRIL STS MODEL 2088TC, AND ARE TRANSVENOUS STEROID ELUTING LEADS INDICATED FOR USE IN THE RIGHT ATRIUM OR RIGHT VENTRICLE, IN COMBINATION WITH A COMPATIBLE PULSE GENERATOR.
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