PMA P810002S113
- Device
- Masters Mechanical Heart Valve
- Applicant
- ABBOTT MEDICAL
- PMA number
- P810002
- Supplement
- S113
- Product code
- LWQ
- Decision date
- 2021-08-19
- Generic name
- HEART-VALVE, MECHANICAL
- Approval order statement
- Approval for labeling changes specific for each valve configuration in a precaution statement in the Instructions for Use.
Current openFDA PMA Record#
- Device
- Masters Mechanical Heart Valve
- Applicant
- ABBOTT MEDICAL
- PMA number
- P810002
- Supplement
- S113
- Product code
- LWQ
- Generic name
- HEART-VALVE, MECHANICAL
- Decision date
- 2021-08-19
- Decision code
- APPR
- Date received
- 2021-07-23
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for labeling changes specific for each valve configuration in a precaution statement in the Instructions for Use.