TENDRIL STS LEAD MODEL 1988TC
FDA premarket approval P960013/S054 · decided 2010-04-14
Approval details
- PMA number
- P960013
- Supplement
- S054
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- TENDRIL STS LEAD MODEL 1988TC
- Generic name
- Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
- Applicant
- ABBOTT MEDICAL
- Date received
- 2009-11-09
- Decision date
- 2010-04-14
- Days to decision
- 156 days
- Decision code
- APPR
- Product code
- NVN
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Sylmar, CA
- Statement
- APPROVAL FOR THE TENDRIL STS MODEL 1988TC LEAD.
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