PMA P910023S440

Device: Avant VR, Neutrino NxT VR, Gallant VR, Entrant VR, Avant DR, Neutrino NxT DR, Gallant DR, Entrant DR
Applicant: ABBOTT MEDICAL
PMA number: P910023
Supplement: S440
Product code: LWS
Decision date: 2021-09-01
Generic name: Implantable cardioverter defibrillator (non-CRT)
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 VR, Neutrino NxT VR, Gallant VR, Entrant VR, Avant DR, Neutrino NxT DR, Gallant DR, Entrant DR
Applicant: ABBOTT MEDICAL
PMA number: P910023
Supplement: S440
Product code: LWS
Generic name: Implantable cardioverter defibrillator (non-CRT)
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.