MEDTRONIC HALL/EASY-FIT PROSTHETIC HEART VALVE
FDA premarket approval P790018/S040 · decided 2001-12-19
Approval details
- PMA number
- P790018
- Supplement
- S040
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- MEDTRONIC HALL/EASY-FIT PROSTHETIC HEART VALVE
- Generic name
- HEART-VALVE, MECHANICAL
- Applicant
- Medtronic Cardiac Surgery
- Date received
- 2001-11-19
- Decision date
- 2001-12-19
- Days to decision
- 30 days
- Decision code
- OK30
- Product code
- LWQ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- ADDITION OF AN ALTERNATE STEAM (AUTOCLAVE) STERILIZER WITH A CHANGE IN STERILIZATION TIME FROM 24 TO 40 MINUTES.
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