PMA P990046S018
- Device
- ATS MECHANICAL HEART VALVES
- Applicant
- Medtronic Ats Medical, Inc.
- PMA number
- P990046
- Supplement
- S018
- Product code
- LWQ
- Decision date
- 2008-09-11
- Generic name
- HEART-VALVE, MECHANICAL
- Approval order statement
- APPROVAL FOR CHANGING THE STERILE PRODUCT RELEASE PROCESS.
Current openFDA PMA Record#
- Device
- ATS MECHANICAL HEART VALVES
- Applicant
- Medtronic Ats Medical, Inc.
- PMA number
- P990046
- Supplement
- S018
- Product code
- LWQ
- Generic name
- HEART-VALVE, MECHANICAL
- Decision date
- 2008-09-11
- Decision code
- APPR
- Date received
- 2007-11-28
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL FOR CHANGING THE STERILE PRODUCT RELEASE PROCESS.