PMA P790018S050
- Device
- MEDTRONIC HALL PROSTHETIC HEART VALVE/EASY-FIT/AORTIC VALVED CONDUIT/COLLAGEN IMPREGNATED CONDUIT/ROTATABLE AORTIC
- Applicant
- Medtronic Cardiac Surgery
- PMA number
- P790018
- Supplement
- S050
- Product code
- LWQ
- Decision date
- 2008-12-09
- Classification
- Heart-valve, Mechanical
- Generic name
- HEART-VALVE, MECHANICAL
- Approval order statement
- USE OF A NEW MODEL AIR SAMPLER.
Current openFDA PMA Record#
- Device
- MEDTRONIC HALL PROSTHETIC HEART VALVE/EASY-FIT/AORTIC VALVED CONDUIT/COLLAGEN IMPREGNATED CONDUIT/ROTATABLE AORTIC
- Applicant
- Medtronic Cardiac Surgery
- PMA number
- P790018
- Supplement
- S050
- Product code
- LWQ
- Generic name
- HEART-VALVE, MECHANICAL
- Decision date
- 2008-12-09
- Decision code
- OK30
- Date received
- 2008-11-10
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- USE OF A NEW MODEL AIR SAMPLER.