Quickflex µ, Quartet
FDA premarket approval P030054/S384 · decided 2020-10-16
Approval details
- PMA number
- P030054
- Supplement
- S384
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- Quickflex µ, Quartet
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Applicant
- ABBOTT MEDICAL
- Date received
- 2020-08-11
- Decision date
- 2020-10-16
- Days to decision
- 66 days
- Decision code
- APPR
- Product code
- NIK
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Sylmar, CA
- Statement
- Approval for the use of an optimized method for the calculation of the amount of DSP content identified on product labels for CRT and passive fixation cardiac leads.
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