MEDTRONIC HALL PROSTHETIC HEART VALVE
FDA premarket approval P790018/S034 · decided 1998-11-16
Approval details
- PMA number
- P790018
- Supplement
- S034
- 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
- 1998-10-27
- Decision date
- 1998-11-16
- Days to decision
- 20 days
- Decision code
- OK30
- Product code
- LWQ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- The 30-day notice requested a change in the supplier of a raw material (yarn) for the device because the current supplier of Polytetrafluoroethylene (PTFE) yarn has chosen to withdraw this material from the implantable medical device industry.
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