MULTI-PARTITION OPERATING ENVIRONMENT (MOE), VERSION 1.0
FDA premarket approval P970024/S002 · decided 1999-02-23
Approval details
- PMA number
- P970024
- Supplement
- S002
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- MULTI-PARTITION OPERATING ENVIRONMENT (MOE), VERSION 1.0
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- MicroPort CRM USA, Inc.
- Date received
- 1999-02-08
- Decision date
- 1999-02-23
- Days to decision
- 15 days
- Decision code
- APPR
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Arlington, TN
- Statement
- Approval for Multi-partition Operating Environment version 1.0.
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