HALL EASY-FIT PROSTHETIC HEART VALVE
FDA premarket approval P790018/S051 · decided 2009-12-18
Approval details
- PMA number
- P790018
- Supplement
- S051
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- HALL EASY-FIT PROSTHETIC HEART VALVE
- Generic name
- HEART-VALVE, MECHANICAL
- Applicant
- Medtronic Cardiac Surgery
- Date received
- 2009-02-24
- Decision date
- 2009-12-18
- Days to decision
- 297 days
- Decision code
- APPR
- Product code
- LWQ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- APPROVAL FOR LABELING CHANGES.
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