Avalus Bioprosthesis Valve
FDA premarket approval P170006/S001 · decided 2017-10-03
Approval details
- PMA number
- P170006
- Supplement
- S001
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Avalus Bioprosthesis Valve
- Generic name
- heart-valve, non-allograft tissue
- Applicant
- Medtronic, Inc. Heart Valve Division
- Date received
- 2017-09-11
- Decision date
- 2017-10-03
- Days to decision
- 22 days
- Decision code
- OK30
- Product code
- LWR
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Santa Ana, CA
- Statement
- Reduction of the sample size for tissue microbial monitoring.
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