MEDTRONIC HALL PROSTHETIC HEART VALVES (MODELS A7700 AND M7700)
FDA premarket approval P790018/S044 · decided 2003-09-23
Approval details
- PMA number
- P790018
- Supplement
- S044
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- MEDTRONIC HALL PROSTHETIC HEART VALVES (MODELS A7700 AND M7700)
- Generic name
- HEART-VALVE, MECHANICAL
- Applicant
- Medtronic Cardiac Surgery
- Date received
- 2003-08-29
- Decision date
- 2003-09-23
- Days to decision
- 25 days
- Decision code
- OK30
- Product code
- LWQ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- ELIMINATION OF THE PRODUCTION PULSE DUPLICATION TEST FROM THE MANUFACTURING PROCESS.
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