HALL EASY-FIT PROSTHETIC HEART VALVE
FDA premarket approval P790018/S042 · decided 2002-01-11
Approval details
- PMA number
- P790018
- Supplement
- S042
- 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
- 2001-12-26
- Decision date
- 2002-01-11
- Days to decision
- 16 days
- Decision code
- APPR
- Product code
- LWQ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- APPROVAL TO INCLUDE ONE ADDITIONAL PRECAUTION STATEMENT TO THE INSTRUCTIONS FOR USE.
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