PMA P810002S119

Device: SJM Masters Series Mechanical Heart Valve, 15mm HP
Applicant: ABBOTT MEDICAL
PMA number: P810002
Supplement: S119
Product code: LWQ
Decision date: 2023-12-04
Classification: Cardiovascular
Generic name: HEART-VALVE, MECHANICAL
Approval order statement: Approval for modifications to the Instructions for Use to reflect the 5-year findings of the Post-Approval Study (PAS) Report submitted for the continued follow-up of the premarket HALO cohort

Current openFDA PMA Record#

Device: SJM Masters Series Mechanical Heart Valve, 15mm HP
Applicant: ABBOTT MEDICAL
PMA number: P810002
Supplement: S119
Product code: LWQ
Generic name: HEART-VALVE, MECHANICAL
Decision date: 2023-12-04
Decision code: APPR
Date received: 2023-06-07
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Labeling Change - PAS
Approval order statement: Approval for modifications to the Instructions for Use to reflect the 5-year findings of the Post-Approval Study (PAS) Report submitted for the continued follow-up of the premarket HALO cohort