AORTIC VALVED GRAFT WITH MEADOX(R) HEMASHIELD(R)
FDA premarket approval P810002/S032 · decided 1994-07-29
Approval details
- PMA number
- P810002
- Supplement
- S032
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- AORTIC VALVED GRAFT WITH MEADOX(R) HEMASHIELD(R)
- Generic name
- HEART-VALVE, MECHANICAL
- Applicant
- ABBOTT MEDICAL
- Date received
- 1994-06-24
- Decision date
- 1994-07-29
- Days to decision
- 35 days
- Decision code
- APPR
- Product code
- LWQ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St. Paul, MN
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