PMA P170006S042
- Device
- Avalus™ Bioprosthesis Model 400 (40019, 40021, 40023, 40025, 40027, 40029); Avalus™ Ultra Bioprosthesis Model 400 (400U1
- Applicant
- Medtronic, Inc.
- PMA number
- P170006
- Supplement
- S042
- Product code
- LWR
- Decision date
- 2026-02-04
- Classification
- Cardiovascular
- Generic name
- heart-valve, non-allograft tissue
- Approval order statement
- an alternative batch testing plan for bacterial endotoxin testing
Current openFDA PMA Record#
- Device
- Avalus™ Bioprosthesis Model 400 (40019, 40021, 40023, 40025, 40027, 40029); Avalus™ Ultra Bioprosthesis Model 400 (400U1
- Applicant
- Medtronic, Inc.
- PMA number
- P170006
- Supplement
- S042
- Product code
- LWR
- Generic name
- heart-valve, non-allograft tissue
- Decision date
- 2026-02-04
- Decision code
- OK30
- Date received
- 2026-01-06
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- an alternative batch testing plan for bacterial endotoxin testing