Edwards Intuity Elite Valve System
FDA premarket approval P150036/S041 · decided 2019-09-24
Approval details
- PMA number
- P150036
- Supplement
- S041
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Edwards Intuity Elite Valve System
- Generic name
- heart-valve, non-allograft tissue
- Applicant
- Edwards Lifesciences, LLC
- Date received
- 2019-08-27
- Decision date
- 2019-09-24
- Days to decision
- 28 days
- Decision code
- OK30
- Product code
- LWR
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- Expansion of the Heart Valve Center Chemical Mixing Suite and increased manning of the Chemical Mixing Suite at the Irvine facility.
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