PMA P060040S126
- Device
- HeartMate II™ Left Ventricular Assist System
- Applicant
- ABBOTT MEDICAL
- PMA number
- P060040
- Supplement
- S126
- Product code
- DSQ
- Decision date
- 2026-08-12
- Classification
- Cardiovascular
- Generic name
- Ventricular (assist) bypass
- Approval order statement
- addition of an alternate supplier for a raw material used in the packaging adhesive
Current openFDA PMA Record#
- Device
- HeartMate II™ Left Ventricular Assist System
- Applicant
- ABBOTT MEDICAL
- PMA number
- P060040
- Supplement
- S126
- Product code
- DSQ
- Generic name
- Ventricular (assist) bypass
- Decision date
- 2026-08-12
- Decision code
- OK30
- Date received
- 2026-07-14
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- addition of an alternate supplier for a raw material used in the packaging adhesive