MEDTRONIC(R) HALL PROSTHETIC HEART VALVE
FDA premarket approval P790018/S032 · decided 1998-07-01
Approval details
- PMA number
- P790018
- Supplement
- S032
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- MEDTRONIC(R) HALL PROSTHETIC HEART VALVE
- Generic name
- HEART-VALVE, MECHANICAL
- Applicant
- Medtronic Cardiac Surgery
- Date received
- 1998-01-30
- Decision date
- 1998-07-01
- Days to decision
- 152 days
- Decision code
- APPR
- Product code
- LWQ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- Approval to manufacture the sewing ring component of the Medtronic Hall(TM) Prosthetic Heart Valves with knitted polytetrafluoroethylene (PTFE) fabric constructed of PTFE yarn from an alternate supplier. The models affected by the change include Model A7700 (sizes 21, 23, 25, 27, 29, and 31 mm) and Model M7700 (sizes 23, 25, 27, 29, and 31 mm).
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