PROGRAMMING SOFTWARE UPGRADE (CSO 4.10 UG)
FDA premarket approval P950029/S009 · decided 1999-11-19
Approval details
- PMA number
- P950029
- Supplement
- S009
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- PROGRAMMING SOFTWARE UPGRADE (CSO 4.10 UG)
- Generic name
- implantable pacemaker Pulse-generator
- Applicant
- MicroPort CRM USA, Inc.
- Date received
- 1999-10-12
- Decision date
- 1999-11-19
- Days to decision
- 38 days
- Decision code
- APPR
- Product code
- DXY
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Arlington, TN
- Statement
- Approval for the CSO 4.10 UG Programmer Software, for use with the ELA programmers.
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