PMA P060040S003
- Device
- HEARTMATE II LVAS
- Applicant
- ABBOTT MEDICAL
- PMA number
- P060040
- Supplement
- S003
- Product code
- DSQ
- Decision date
- 2009-01-08
- Classification
- Ventricular (assist) Bypass
- Generic name
- Ventricular (assist) bypass
- Approval order statement
- APPROVAL FOR REVISED LABELING FOR THE HEARTMATE II LVAS REGARDING POTENTIAL DAMAGE TO THE PERCUTANEOUS LEAD RESULTING FROM WEAR AND FATIGUE.
Current openFDA PMA Record#
- Device
- HEARTMATE II LVAS
- Applicant
- ABBOTT MEDICAL
- PMA number
- P060040
- Supplement
- S003
- Product code
- DSQ
- Generic name
- Ventricular (assist) bypass
- Decision date
- 2009-01-08
- Decision code
- APPR
- Date received
- 2008-12-19
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- APPROVAL FOR REVISED LABELING FOR THE HEARTMATE II LVAS REGARDING POTENTIAL DAMAGE TO THE PERCUTANEOUS LEAD RESULTING FROM WEAR AND FATIGUE.