EPIC VALVE
FDA premarket approval P040021/S020 · decided 2012-11-01
Approval details
- PMA number
- P040021
- Supplement
- S020
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- EPIC VALVE
- Generic name
- HEART-VALVE, MECHANICAL
- Applicant
- ABBOTT MEDICAL
- Date received
- 2011-08-17
- Decision date
- 2012-11-01
- Days to decision
- 442 days
- Decision code
- APPR
- Product code
- LWQ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St. Paul, MN
- Statement
- APPROVAL TO UPDATE THE INSTRUCTIONS FOR USE (IFU), ST. JUDE MEDICAL (SJM) INTERNET, AND ANY OTHER APPLICABLE DEVICE LABELING TO INCLUDE THE NEW MAGNETIC RESONANCE IMAGING (MRI) TESTING INFORMATION TO ENHANCE THE SAFE USE OF THE DEVICE WHEN UNDERGOING MRI.
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