ST. JUDE MEDICAL MECHANICAL HEART VALVE
FDA premarket approval P810002/S054 · decided 2000-10-23
Approval details
- PMA number
- P810002
- Supplement
- S054
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- ST. JUDE MEDICAL MECHANICAL HEART VALVE
- Generic name
- HEART-VALVE, MECHANICAL
- Applicant
- ABBOTT MEDICAL
- Date received
- 2000-09-27
- Decision date
- 2000-10-23
- Days to decision
- 26 days
- Decision code
- APPR
- Product code
- LWQ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St. Paul, MN
- Statement
- APPROVAL FOR A CHANGE TO THE AORTIC POLYESTER CUFF CONFIGURATION OF THE SJM(R) MASTER SERIES HP VALVE. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME SJM(R) MASTER SERIES HEMODYNAMIC PLUS (HP) WITH FLEX CUFF(TM), MODEL AFHPJ-505, AVAILABLE IN AORTIC SIZES 17, 19, 21, 23, 25, AND 27 MM.
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