STARR-EDWARDS SILASTIC BALL HEART VALVE, MODELS 1260 AND 6120
FDA premarket approval P870038/S011 · decided 2007-01-19
Approval details
- PMA number
- P870038
- Supplement
- S011
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- STARR-EDWARDS SILASTIC BALL HEART VALVE, MODELS 1260 AND 6120
- Generic name
- HEART-VALVE, MECHANICAL
- Applicant
- Edwards Lifesciences, LLC
- Date received
- 2006-10-06
- Decision date
- 2007-01-19
- Days to decision
- 105 days
- Decision code
- APPR
- Product code
- LWQ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- APPROVAL FOR A MINOR DESIGN CHANGE AND CHANGE IN MATERIAL SUPPLIER.
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