MEDTRONIC HALL PROSTHETIC HEART VALVE /HALL EASY FIT
FDA premarket approval P790018/S045 · decided 2003-11-28
Approval details
- PMA number
- P790018
- Supplement
- S045
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Express GMP Supplement
- Trade name
- MEDTRONIC HALL PROSTHETIC HEART VALVE /HALL EASY FIT
- Generic name
- HEART-VALVE, MECHANICAL
- Applicant
- Medtronic Cardiac Surgery
- Date received
- 2003-11-12
- Decision date
- 2003-11-28
- Days to decision
- 16 days
- Decision code
- APPR
- Product code
- LWQ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- APPROVAL FOR A MANUFACTURING SITE LOCATED AT BIOTEST LABORATORIES, INC. MINNEAPOLIS, MINNESOTA.
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