Avant HF, Neutrino NxT HF, Gallant HF and Entrant HF CRT-D
FDA premarket approval P030054/S381 · decided 2020-09-15
Approval details
- PMA number
- P030054
- Supplement
- S381
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Avant HF, Neutrino NxT HF, Gallant HF and Entrant HF CRT-D
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Applicant
- ABBOTT MEDICAL
- Date received
- 2020-07-09
- Decision date
- 2020-09-15
- Days to decision
- 68 days
- Decision code
- APPR
- Product code
- NIK
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Sylmar, CA
- Statement
- Approval for use of a pre-molded header utilizing a one-piece contact assembly in lieu of a two-piece contact assembly.
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