ACUITYX4 Lead Straight, ACUITY X4 Lead Spiral S, ACUITY X4 Lead Spiral L and Suture Sleeve Accessory

FDA premarket approval P010012/S484 · decided 2018-07-27

Approval details

PMA number

P010012

Supplement

S484

Supplement type

Normal 180 Day Track

Supplement reason

Change Design/Components/Specifications/Material

Trade name

ACUITYX4 Lead Straight, ACUITY X4 Lead Spiral S, ACUITY X4 Lead Spiral L and Suture Sleeve Accessory

Generic name

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

Applicant

Boston Scientific Corp

Date received

2018-04-30

Decision date

2018-07-27

Days to decision

88 days

Decision code

APPR

Product code

NIK

Advisory committee

Cardiovascular

Expedited review

No

Location

St Paul, MN

Statement

Approval for firmware modifications for the Ingenio and Accolade families of pacemaker and cardiac resynchronization therapy-pacemaker pulse generators and the associated Programmer Software Applications to support the addition of features including Signal Artifact Monitor, Automatic Lead Recognition, MRI Protection Mode, and RightRate pacing. The device, as modified, will be marketed under the trade names listed for pacemakers and CRT P devices.. Adaptive rate pacing is indicated for patients e

510(k) clearances by this applicant