MULTI-PARTITION OPERATING ENVIRONMENT FOR ELA PROGRAMMERS
FDA premarket approval P950029/S008 · decided 1999-12-03
Approval details
- PMA number
- P950029
- Supplement
- S008
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- MULTI-PARTITION OPERATING ENVIRONMENT FOR ELA PROGRAMMERS
- Generic name
- implantable pacemaker Pulse-generator
- Applicant
- MicroPort CRM USA, Inc.
- Date received
- 1999-09-16
- Decision date
- 1999-12-03
- Days to decision
- 78 days
- Decision code
- APPR
- Product code
- DXY
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Arlington, TN
- Statement
- Approval for the Multi-Partition Operating Environment to be used on ELA Medical programmers.
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