MEDTRONIC HALL PROSTHETIC HEART VALVE
FDA premarket approval P790018/S036 · decided 2000-11-09
Approval details
- PMA number
- P790018
- Supplement
- S036
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- MEDTRONIC HALL PROSTHETIC HEART VALVE
- Generic name
- HEART-VALVE, MECHANICAL
- Applicant
- Medtronic Cardiac Surgery
- Date received
- 2000-10-17
- Decision date
- 2000-11-09
- Days to decision
- 23 days
- Decision code
- OK30
- Product code
- LWQ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- ALTERNATE SUPPLIER FOR THE POLYTETRAFLUOROETHYLENE (PTFE) FABRIC CONSTRUCTED OF PTFE YARN. THIS FABRIC IS USED TO MANUFACTURE THE SEWING RING COMPONENT FOR THE MEDTRONIC HALL PROSTHETIC HEART VALVE, MODEL A7700, SIZES 20, 22, AND 24 MM.
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