MEDTRONIC(R) HALL PROSTHETIC HEART VALVE
FDA premarket approval P790018/S033 · decided 1998-08-06
Approval details
- PMA number
- P790018
- Supplement
- S033
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- MEDTRONIC(R) HALL PROSTHETIC HEART VALVE
- Generic name
- HEART-VALVE, MECHANICAL
- Applicant
- Medtronic Cardiac Surgery
- Date received
- 1998-07-14
- Decision date
- 1998-08-06
- Days to decision
- 23 days
- Decision code
- APPR
- Product code
- LWQ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- Approval for relocation of manufacturing facility from Medtronic, Inc., Cardiovascular Business Center, Minneapolis, MN, to Medtronic, Inc., 8299 Central Ave., NE, Spring Lake Park, MN.
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