TENDRIL AND OPTISENSE LEAD FAMILIES
FDA premarket approval P960013/S071 · decided 2012-04-13
Approval details
- PMA number
- P960013
- Supplement
- S071
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- TENDRIL AND OPTISENSE LEAD FAMILIES
- Generic name
- Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
- Applicant
- ABBOTT MEDICAL
- Date received
- 2012-02-14
- Decision date
- 2012-04-13
- Days to decision
- 59 days
- Decision code
- APPR
- Product code
- NVN
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Sylmar, CA
- Statement
- APPROVAL FOR MODIFICATION TO THE CONNECTOR BOOT ON THE ISOFLEX TENDRIL ST, TENDRIL STS, AND OPTISENSE LEAD MODELS, TENDRIL ST MODELS 1882, 1888, TENDRIL STS MODELS 1988, 2088 AND OPTISENSE MODEL 1999.
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