PMA P980012S006

Device: WORLD HEART NOVACOR N100PC AND N100PCQ :VAS
Applicant: Worldheart, Inc.
PMA number: P980012
Supplement: S006
Product code: DSQ
Decision date: 2004-07-21
Generic name: Ventricular (assist) bypass
Approval order statement: APPROVAL FOR MODIFICATIONS TO THE DEVICE SYSTEM LABELING; SPECIFICALLY, CHANGES TO (ONLY) THE DEVICE RELIABILITY PORTION OF SECTION 7 (CLINICAL STUDY) OF THE PHYSICIAN'S MANUAL.

Current openFDA PMA Record

Device: WORLD HEART NOVACOR N100PC AND N100PCQ :VAS
Applicant: Worldheart, Inc.
PMA number: P980012
Supplement: S006
Product code: DSQ
Generic name: Ventricular (assist) bypass
Decision date: 2004-07-21
Decision code: APPR
Date received: 2004-03-10
Supplement type: Real-Time Process
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: APPROVAL FOR MODIFICATIONS TO THE DEVICE SYSTEM LABELING; SPECIFICALLY, CHANGES TO (ONLY) THE DEVICE RELIABILITY PORTION OF SECTION 7 (CLINICAL STUDY) OF THE PHYSICIAN'S MANUAL.