PMA P980012S003
- Device
- NOVACOR N100PC LVAS WITH OPTIONAL EPTFE INFLOW CONDUIT
- Applicant
- Worldheart, Inc.
- PMA number
- P980012
- Supplement
- S003
- Product code
- DSQ
- Decision date
- 2003-01-10
- Generic name
- Ventricular (assist) bypass
- Approval order statement
- APPROVAL FOR OPTIONAL USE OF THE RE-DESIGNED EPTFE INFLOW CONDUIT WITH THE NOVACOR N100PC LVAS DEVICE SYSTEM.
Current openFDA PMA Record
- Device
- NOVACOR N100PC LVAS WITH OPTIONAL EPTFE INFLOW CONDUIT
- Applicant
- Worldheart, Inc.
- PMA number
- P980012
- Supplement
- S003
- Product code
- DSQ
- Generic name
- Ventricular (assist) bypass
- Decision date
- 2003-01-10
- Decision code
- APPR
- Date received
- 2002-06-11
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR OPTIONAL USE OF THE RE-DESIGNED EPTFE INFLOW CONDUIT WITH THE NOVACOR N100PC LVAS DEVICE SYSTEM.