PMA P790018S048
- Device
- MEDTRONIC HALL ROTATABLE AORTIC VALVED COLLAGEN IMPREGNATED CONDUIT
- Applicant
- Medtronic Cardiac Surgery
- PMA number
- P790018
- Supplement
- S048
- Product code
- LWQ
- Decision date
- 2008-06-26
- Classification
- Heart-valve, Mechanical
- Generic name
- HEART-VALVE, MECHANICAL
- Approval order statement
- CHANGE IN RAW MATERIAL SUPPLIER.
Current openFDA PMA Record#
- Device
- MEDTRONIC HALL ROTATABLE AORTIC VALVED COLLAGEN IMPREGNATED CONDUIT
- Applicant
- Medtronic Cardiac Surgery
- PMA number
- P790018
- Supplement
- S048
- Product code
- LWQ
- Generic name
- HEART-VALVE, MECHANICAL
- Decision date
- 2008-06-26
- Decision code
- OK30
- Date received
- 2008-05-27
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- CHANGE IN RAW MATERIAL SUPPLIER.