Promote/+/RF/Q, Promote Accel, Promote Quadra, Unify, Unify Assura, Unify Quadra, Quadra Assura, Epic+/HF/HF+/ II HF/ II

FDA premarket approval P030054/S329 · decided 2017-08-23

Approval details

PMA number

P030054

Supplement

S329

Supplement type

Normal 180 Day Track

Supplement reason

Change Design/Components/Specifications/Material

Trade name

Promote/+/RF/Q, Promote Accel, Promote Quadra, Unify, Unify Assura, Unify Quadra, Quadra Assura, Epic+/HF/HF+/ II HF/ II

Generic name

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

Applicant

ABBOTT MEDICAL

Date received

2017-05-17

Decision date

2017-08-23

Days to decision

98 days

Decision code

APPR

Product code

NIK

Advisory committee

Cardiovascular

Expedited review

No

Location

Sylmar, CA

Statement

Approval for cybersecurity updates to the firmware of low voltage devices, cybersecurity updates to the clinician programmer, and updates to the programmer and Merlin.net server to detect rapid battery depletion in high voltage devices.

510(k) clearances by this applicant