PHYLAX IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SYSTEM

P980023 · Biotronik, Inc. · LWS · Oct 27, 1998 · Cardiovascular

Device Facts

• Record ID: P980023
• Device Name: PHYLAX IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SYSTEM
• Applicant: Biotronik, Inc.
• Product Code: LWS · Cardiovascular
• Decision Date: Oct 27, 1998
• Decision: APPR
• Device Class: Class 3

Regulatory Classification

Identification

These devices treat tachycardia (fast heartbeats) with RV defibrillation therapy as necessary.