MEDTRONIC HALL
FDA premarket approval P790018/S046 · decided 2006-11-07
Approval details
- PMA number
- P790018
- Supplement
- S046
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- MEDTRONIC HALL
- Generic name
- HEART-VALVE, MECHANICAL
- Applicant
- Medtronic Cardiac Surgery
- Date received
- 2006-05-10
- Decision date
- 2006-11-07
- Days to decision
- 181 days
- Decision code
- APPR
- Product code
- LWQ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- APPROVAL FOR THE ADDITION OF A PAPERLESS CHART RECORDER TO THE STERILIZATION OPERATIONS.
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