Who is the manufacturer of MODEL 4553 DUAL CHAM. DDD TEMP.CARDIAC PACEMAKER?

Pace Medical filed the PMA application for MODEL 4553 DUAL CHAM. DDD TEMP.CARDIAC PACEMAKER (P920032).

What is the FDA product code for MODEL 4553 DUAL CHAM. DDD TEMP.CARDIAC PACEMAKER?

JOQ. It is classified under 21 CFR 870.1750 as a Class 2 device in the Cardiovascular panel.

Who can help prepare an FDA PMA submission like MODEL 4553 DUAL CHAM. DDD TEMP.CARDIAC PACEMAKER?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA PMA submissions. See https://innolitics.com/services/regulatory/ or contact https://innolitics.com/contact.

MODEL 4553 DUAL CHAM. DDD TEMP.CARDIAC PACEMAKER

P920032 · Pace Medical · JOQ · Mar 10, 1994 · Cardiovascular

Device Facts

Record ID	P920032
Device Name	MODEL 4553 DUAL CHAM. DDD TEMP.CARDIAC PACEMAKER
Applicant	Pace Medical
Product Code	JOQ · Cardiovascular
Decision Date	Mar 10, 1994
Decision	APPR
Regulation	21 CFR 870.1750
Device Class	Class 2

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