TENDRIL FAMILY OF LEADS
FDA premarket approval P960013/S068 · decided 2012-09-13
Approval details
- PMA number
- P960013
- Supplement
- S068
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- TENDRIL FAMILY OF LEADS
- Generic name
- Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
- Applicant
- ABBOTT MEDICAL
- Date received
- 2011-11-07
- Decision date
- 2012-09-13
- Days to decision
- 311 days
- Decision code
- APPR
- Product code
- NVN
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Sylmar, CA
- Statement
- APPROVAL FOR DESIGN CHANGES TO THE HELIX-SHAFT SUBASSEMBLY OF MARKET APPROVED TENDRIL MODELS 1882, 1888, 1988, 2088 AND DURATA MODELS 7120Q, 7121Q, 7122Q, 7120, 7121, 7122, 7130, AND 7131 LEADS FOR IMPROVED MANUFACTURABILITY AND COST.
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