PMA P060040S013
- Device
- HEARTMATE II LVAS
- Applicant
- ABBOTT MEDICAL
- PMA number
- P060040
- Supplement
- S013
- Product code
- DSQ
- Decision date
- 2010-10-08
- Classification
- Ventricular (assist) Bypass
- Generic name
- Ventricular (assist) bypass
- Approval order statement
- APPROVAL FOR REVISED OPERATOR MANUAL AND PATIENT HANDBOOK LABELING FOR THE DEVICE.
Current openFDA PMA Record#
- Device
- HEARTMATE II LVAS
- Applicant
- ABBOTT MEDICAL
- PMA number
- P060040
- Supplement
- S013
- Product code
- DSQ
- Generic name
- Ventricular (assist) bypass
- Decision date
- 2010-10-08
- Decision code
- APPR
- Date received
- 2010-09-17
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- APPROVAL FOR REVISED OPERATOR MANUAL AND PATIENT HANDBOOK LABELING FOR THE DEVICE.