PMA P790018S052
- Device
- MEDTRONIC HALL ROTATABLE AORTIC VALVE COLLAGEN IMPREGNATED CONDUIT
- Applicant
- Medtronic Cardiac Surgery
- PMA number
- P790018
- Supplement
- S052
- Product code
- LWQ
- Decision date
- 2009-07-09
- Classification
- Heart-valve, Mechanical
- Generic name
- HEART-VALVE, MECHANICAL
- Approval order statement
- CHANGES TO THE BIOBURDEN TESTING AND CHANGE TO THE STERILIZATION TEST METHODS.
Current openFDA PMA Record#
- Device
- MEDTRONIC HALL ROTATABLE AORTIC VALVE COLLAGEN IMPREGNATED CONDUIT
- Applicant
- Medtronic Cardiac Surgery
- PMA number
- P790018
- Supplement
- S052
- Product code
- LWQ
- Generic name
- HEART-VALVE, MECHANICAL
- Decision date
- 2009-07-09
- Decision code
- OK30
- Date received
- 2009-06-09
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- CHANGES TO THE BIOBURDEN TESTING AND CHANGE TO THE STERILIZATION TEST METHODS.