ABIOMED AB5000 CIRCULATORY SUPPORT SYSTEM
FDA premarket approval P900023/S039 · decided 2003-12-23
Approval details
- PMA number
- P900023
- Supplement
- S039
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- ABIOMED AB5000 CIRCULATORY SUPPORT SYSTEM
- Generic name
- Ventricular (assist) bypass
- Applicant
- Abiomed Cardiovascular, Inc.
- Date received
- 2003-12-15
- Decision date
- 2003-12-23
- Days to decision
- 8 days
- Decision code
- APPR
- Product code
- DSQ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Danvers, MA
- Statement
- APPROVAL FOR AN ADDITIONAL LABEL IN THE FORM OF A PACKAGING STICKER STATING, "ONLY USE THREADED RESTRAINTS WITH THE AB5000 VENTRICLE. USE OF NON-THREADED CANNULA RESTRAINTS MAY RESULT IN: 1) CANNULAE BECOMING DISCONNECTED FROM THE VENTRICLE, AND 2) THROMBUS FORMATION."
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.