QuickFlex u 1258T LV Lead
FDA premarket approval P030054/S359 · decided 2018-10-09
Approval details
- PMA number
- P030054
- Supplement
- S359
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- QuickFlex u 1258T LV Lead
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Applicant
- ABBOTT MEDICAL
- Date received
- 2018-07-25
- Decision date
- 2018-10-09
- Days to decision
- 76 days
- Decision code
- APPR
- Product code
- NIK
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Sylmar, CA
- Statement
- Approval for labeling updates to the clinical study summary for the post approval study.
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