BRIO, TALENT, AND OPUS PACEMAKERS AND PROGRAMMER SOFTWARE
FDA premarket approval P950029/S013 · decided 2001-02-02
Approval details
- PMA number
- P950029
- Supplement
- S013
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- BRIO, TALENT, AND OPUS PACEMAKERS AND PROGRAMMER SOFTWARE
- Generic name
- implantable pacemaker Pulse-generator
- Applicant
- MicroPort CRM USA, Inc.
- Date received
- 2001-01-11
- Decision date
- 2001-02-02
- Days to decision
- 22 days
- Decision code
- APPR
- Product code
- DXY
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Arlington, TN
- Statement
- APPROVAL FOR A NEW DIGITAL PACING CHIP, THE LOGAUTO H5, BRIO AND TALENT FIRMWARE MASK L4, AND CSO VERSION 4.16UG PROGRAMMER SOFTWARE.
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