PMA P030054S395

Device: Avant HF, Neutrino NxT HF, Gallant HF, Entrant HF,
Applicant: ABBOTT MEDICAL
PMA number: P030054
Supplement: S395
Product code: NIK
Decision date: 2021-09-01
Generic name: Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
Approval order statement: Acceptance to add an alternate supplier of connector assemblies that will be mounted on the hybrids for ICD and CRT-D devices.

Current openFDA PMA Record#

Device: Avant HF, Neutrino NxT HF, Gallant HF, Entrant HF,
Applicant: ABBOTT MEDICAL
PMA number: P030054
Supplement: S395
Product code: NIK
Generic name: Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
Decision date: 2021-09-01
Decision code: OK30
Date received: 2021-08-04
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Acceptance to add an alternate supplier of connector assemblies that will be mounted on the hybrids for ICD and CRT-D devices.