MAXIMO II ICD, MAXIMO II M4, PROTECTA ICD, PROTECTA M4, XT ICD, PROTECTA XT M4, SECURA ICD, SECURA M4, VIRTUOSO II DR/VR
FDA premarket approval P010031/S300 · decided 2012-05-04
Approval details
- PMA number
- P010031
- Supplement
- S300
- Supplement type
- 30-Day Notice
- Trade name
- MAXIMO II ICD, MAXIMO II M4, PROTECTA ICD, PROTECTA M4, XT ICD, PROTECTA XT M4, SECURA ICD, SECURA M4, VIRTUOSO II DR/VR
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2012-04-06
- Decision date
- 2012-05-04
- Days to decision
- 28 days
- Decision code
- OK30
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- SOFTWARE UPGRADE TO AN EXISTING TEST EQUIPMENT.
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