PMA P810002S111
- Device
- Mechanical Heart Valve
- Applicant
- ABBOTT MEDICAL
- PMA number
- P810002
- Supplement
- S111
- Product code
- LWQ
- Decision date
- 2020-05-12
- Generic name
- HEART-VALVE, MECHANICAL
- Approval order statement
- Alternative BET batch sampling plan.
Current openFDA PMA Record#
- Device
- Mechanical Heart Valve
- Applicant
- ABBOTT MEDICAL
- PMA number
- P810002
- Supplement
- S111
- Product code
- LWQ
- Generic name
- HEART-VALVE, MECHANICAL
- Decision date
- 2020-05-12
- Decision code
- OK30
- Date received
- 2020-04-28
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Alternative BET batch sampling plan.