PMA P900023S051
- Device
- IPULSE CIRCULATORY SUPPORT SYSTEM
- Applicant
- Abiomed Cardiovascular, Inc.
- PMA number
- P900023
- Supplement
- S051
- Product code
- DSQ
- Decision date
- 2009-06-05
- Classification
- Ventricular (assist) Bypass
- Generic name
- Ventricular (assist) bypass
- Approval order statement
- APPROVAL FOR AN INCREASED FIELD SERVICE INTERVAL OF 5000 HOURS FOR THE IPULSE CONSOLE.
Current openFDA PMA Record#
- Device
- IPULSE CIRCULATORY SUPPORT SYSTEM
- Applicant
- Abiomed Cardiovascular, Inc.
- PMA number
- P900023
- Supplement
- S051
- Product code
- DSQ
- Generic name
- Ventricular (assist) bypass
- Decision date
- 2009-06-05
- Decision code
- APPR
- Date received
- 2009-04-07
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR AN INCREASED FIELD SERVICE INTERVAL OF 5000 HOURS FOR THE IPULSE CONSOLE.