IPULSE CIRCULATORY SUPPORT SYSTEM
FDA premarket approval P900023/S051 · decided 2009-06-05
Approval details
- PMA number
- P900023
- Supplement
- S051
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- IPULSE CIRCULATORY SUPPORT SYSTEM
- Generic name
- Ventricular (assist) bypass
- Applicant
- Abiomed Cardiovascular, Inc.
- Date received
- 2009-04-07
- Decision date
- 2009-06-05
- Days to decision
- 59 days
- Decision code
- APPR
- Product code
- DSQ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Danvers, MA
- Statement
- APPROVAL FOR AN INCREASED FIELD SERVICE INTERVAL OF 5000 HOURS FOR THE IPULSE CONSOLE.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.