MEDTRONIC HALL PROSTHETIC HEART VALVES A7700 AND M7700
FDA premarket approval P790018/S039 · decided 2001-12-04
Approval details
- PMA number
- P790018
- Supplement
- S039
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- MEDTRONIC HALL PROSTHETIC HEART VALVES A7700 AND M7700
- Generic name
- HEART-VALVE, MECHANICAL
- Applicant
- Medtronic Cardiac Surgery
- Date received
- 2001-11-05
- Decision date
- 2001-12-04
- Days to decision
- 29 days
- Decision code
- APPR
- Product code
- LWQ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- APPROVAL FOR A NEW MANUFACTURING FACILITY LOCATED AT MEDTRONIC, INC., SPRING LAKE PARK, MINNESOTA.
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