MEDTRONIC-HALL PROSTHETIC HEART VALVE
FDA premarket approval P790018/S027 · decided 1996-08-19
Approval details
- PMA number
- P790018
- Supplement
- S027
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- MEDTRONIC-HALL PROSTHETIC HEART VALVE
- Generic name
- HEART-VALVE, MECHANICAL
- Applicant
- Medtronic Cardiac Surgery
- Date received
- 1996-03-05
- Decision date
- 1996-08-19
- Days to decision
- 167 days
- Decision code
- APPR
- Product code
- LWQ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- APPROVAL FOR THE TRANSFER OF SEWING RING FABRICATION AND ATTACHMENT, AND STERILE PACKAGING MANUFACTURING PROCESSES FROM YOUR FACILITY LOCATED AT 7000 CENTRAL AVE., MINNEAPOLIS, MN TO YOUR FACILITY AT 18011 S.MITCHELL, IRVINE, CA
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