Avant HF, Neutrino NxT HF, Gallant HF, Entrant HF,

FDA premarket approval P030054/S395 · decided 2021-09-01

Approval details

PMA number

P030054

Supplement

S395

Supplement type

30-Day Notice

Supplement reason

Process Change - Manufacturer/Sterilizer/Packager/Supplier

Trade name

Avant HF, Neutrino NxT HF, Gallant HF, Entrant HF,

Generic name

Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)

Applicant

ABBOTT MEDICAL

Date received

2021-08-04

Decision date

2021-09-01

Days to decision

28 days

Decision code

OK30

Product code

NIK

Advisory committee

Cardiovascular

Expedited review

No

Location

Sylmar, CA

Statement

Acceptance to add an alternate supplier of connector assemblies that will be mounted on the hybrids for ICD and CRT-D devices.

510(k) clearances by this applicant