NOVACOR N100PCQ LVAS
FDA premarket approval P980012/S005 · decided 2004-01-02
Approval details
- PMA number
- P980012
- Supplement
- S005
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- NOVACOR N100PCQ LVAS
- Generic name
- Ventricular (assist) bypass
- Applicant
- Worldheart, Inc.
- Date received
- 2003-01-27
- Decision date
- 2004-01-02
- Days to decision
- 340 days
- Decision code
- APPR
- Product code
- DSQ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Oakland, CA
- Statement
- APPROVAL FOR SEVERAL SPECIFIC ENGINEERING ENHANCEMENTS TO THE IMPLANTED (PUMP/DRIVE UNIT, BLOOD CONDUITS, AND PERCUTANEOUS LEAD) COMPONENTS OF THE NOVACOR N100PC LVAS SYSTEM AS WELL AS MODIFICATIONS TO THE SOFTWARE TO UPGRADE TO THE N100PCQ LVAS SYSTEM. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME NOVACOR N100PCQ LVAS SYSTEM AND IS INDICATED FOR USE AS A BRIDGE TO TRANSPLANTATION IN CARDIAC TRANSPLANT CANDIDATES AT RISK OF IMMINENT DEATH FROM NONREVERSIBLE LEFT VENTRICULAR FUNC
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.