PMA P790018S045
- Device
- MEDTRONIC HALL PROSTHETIC HEART VALVE /HALL EASY FIT
- Applicant
- Medtronic Cardiac Surgery
- PMA number
- P790018
- Supplement
- S045
- Product code
- LWQ
- Decision date
- 2003-11-28
- Generic name
- HEART-VALVE, MECHANICAL
- Approval order statement
- APPROVAL FOR A MANUFACTURING SITE LOCATED AT BIOTEST LABORATORIES, INC. MINNEAPOLIS, MINNESOTA.
Current openFDA PMA Record#
- Device
- MEDTRONIC HALL PROSTHETIC HEART VALVE /HALL EASY FIT
- Applicant
- Medtronic Cardiac Surgery
- PMA number
- P790018
- Supplement
- S045
- Product code
- LWQ
- Generic name
- HEART-VALVE, MECHANICAL
- Decision date
- 2003-11-28
- Decision code
- APPR
- Date received
- 2003-11-12
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Express GMP Supplement
- Approval order statement
- APPROVAL FOR A MANUFACTURING SITE LOCATED AT BIOTEST LABORATORIES, INC. MINNEAPOLIS, MINNESOTA.