SILASTIC BALL HEART VALVE PROSTHESIS
FDA premarket approval P870038/S010 · decided 2007-01-18
Approval details
- PMA number
- P870038
- Supplement
- S010
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- SILASTIC BALL HEART VALVE PROSTHESIS
- Generic name
- HEART-VALVE, MECHANICAL
- Applicant
- Edwards Lifesciences, LLC
- Date received
- 2006-09-26
- Decision date
- 2007-01-18
- Days to decision
- 114 days
- Decision code
- APPR
- Product code
- LWQ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- APPROVAL FOR CHANGING THE NUMBER OF TURNS PER METER TO THE SEWING THREAD.
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