PMA P790018S035
- Device
- MEDTRONIC HALL PROSTHETIC HEART VALVE, AORTIC VALVED CONDUIT, AORTIC VALVED COLLAGEN IMPREGNATED CONDUIT
- Applicant
- Medtronic Cardiac Surgery
- PMA number
- P790018
- Supplement
- S035
- Product code
- LWQ
- Decision date
- 1999-09-29
- Classification
- Heart-valve, Mechanical
- Generic name
- HEART-VALVE, MECHANICAL
- Approval order statement
- Approval to relocate Medtronic's heart valve manufacturing facility from Irvine, CA, to 1851 East Deere Avenue, Santa Ana, CA.
Current openFDA PMA Record#
- Device
- MEDTRONIC HALL PROSTHETIC HEART VALVE, AORTIC VALVED CONDUIT, AORTIC VALVED COLLAGEN IMPREGNATED CONDUIT
- Applicant
- Medtronic Cardiac Surgery
- PMA number
- P790018
- Supplement
- S035
- Product code
- LWQ
- Generic name
- HEART-VALVE, MECHANICAL
- Decision date
- 1999-09-29
- Decision code
- APPR
- Date received
- 1999-08-31
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Express GMP Supplement
- Approval order statement
- Approval to relocate Medtronic's heart valve manufacturing facility from Irvine, CA, to 1851 East Deere Avenue, Santa Ana, CA.