PMA P900023S047

Device: IPULSE CIRCULATORY SUPPORT SYSTEM
Applicant: Abiomed Cardiovascular, Inc.
PMA number: P900023
Supplement: S047
Product code: DSQ
Decision date: 2007-12-11
Classification: Ventricular (assist) Bypass
Generic name: Ventricular (assist) bypass
Approval order statement: APPROVAL FOR THE IPULSE CIRCULATORY SUPPORT SYSTEM, A UNIT THAT WILL SUPPORT PATIENTS IN NEED OF FULL CIRCULATORY SUPPORT USING THE BVS 5000 BLOOD PUMP OR THE AB5000 VENTRICLE, OR PARTIAL VENTRICULAR ASSIST USING THE APPROVED INTRA-AORTIC BALLOON PUMP (IABP). THE DEVICE CONSOLE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME IPULSE CIRCULATORY SUPPORT SYSTEM AND IS INDICATED FOR USE IN CONJUNCTION WITH THE ABIOMED AB 5000 VENTRICLE AND THE BVS 5000 BLOOD PUMP.

Current openFDA PMA Record#

Device: IPULSE CIRCULATORY SUPPORT SYSTEM
Applicant: Abiomed Cardiovascular, Inc.
PMA number: P900023
Supplement: S047
Product code: DSQ
Generic name: Ventricular (assist) bypass
Decision date: 2007-12-11
Decision code: APPR
Date received: 2006-11-13
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR THE IPULSE CIRCULATORY SUPPORT SYSTEM, A UNIT THAT WILL SUPPORT PATIENTS IN NEED OF FULL CIRCULATORY SUPPORT USING THE BVS 5000 BLOOD PUMP OR THE AB5000 VENTRICLE, OR PARTIAL VENTRICULAR ASSIST USING THE APPROVED INTRA-AORTIC BALLOON PUMP (IABP). THE DEVICE CONSOLE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME IPULSE CIRCULATORY SUPPORT SYSTEM AND IS INDICATED FOR USE IN CONJUNCTION WITH THE ABIOMED AB 5000 VENTRICLE AND THE BVS 5000 BLOOD PUMP.