PMA P990046S046
- Device
- ATS OPEN PIVOT BILEAFLET HEART VALVE
- Applicant
- Medtronic Ats Medical, Inc.
- PMA number
- P990046
- Supplement
- S046
- Product code
- LWQ
- Decision date
- 2016-03-10
- Generic name
- HEART-VALVE, MECHANICAL
- Approval order statement
- Change to an alternate test facility and alternate test method for bacterial endotoxin testing.
Current openFDA PMA Record#
- Device
- ATS OPEN PIVOT BILEAFLET HEART VALVE
- Applicant
- Medtronic Ats Medical, Inc.
- PMA number
- P990046
- Supplement
- S046
- Product code
- LWQ
- Generic name
- HEART-VALVE, MECHANICAL
- Decision date
- 2016-03-10
- Decision code
- OK30
- Date received
- 2016-02-18
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Change to an alternate test facility and alternate test method for bacterial endotoxin testing.