CARBOMEDICS PROSTHETIC HEART VALVE
FDA premarket approval P900060/S041 · decided 2011-12-21
Approval details
- PMA number
- P900060
- Supplement
- S041
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- CARBOMEDICS PROSTHETIC HEART VALVE
- Generic name
- HEART-VALVE, MECHANICAL
- Applicant
- Corcym S.r.l.
- Date received
- 2011-02-28
- Decision date
- 2011-12-21
- Days to decision
- 296 days
- Decision code
- APPR
- Product code
- LWQ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Saluggia
- Statement
- APPROVAL TO EXTEND THE MAGNETIC RESONANCE IMAGING (MRI) COMPATIBILITY FROM 1.5 TESLA TO 3.0 TESLA AND TO INCORPORATE OTHER LABELING REVISIONS FOR THE PURPOSE OF UNIFYING AND REBRANDING THE US MARKET LABELS WITH OTHER, NON-US MARKET LABELS.
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