BRIO CARDIAC PACEMAKERS
FDA premarket approval P950029/S007 · decided 1999-09-16
Approval details
- PMA number
- P950029
- Supplement
- S007
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- BRIO CARDIAC PACEMAKERS
- Generic name
- implantable pacemaker Pulse-generator
- Applicant
- MicroPort CRM USA, Inc.
- Date received
- 1999-08-26
- Decision date
- 1999-09-16
- Days to decision
- 21 days
- Decision code
- APPR
- Product code
- DXY
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Arlington, TN
- Statement
- Approval for the introduction of version 5 of the Brio pacemakers, including the introudction ofthe dedicated bipolar Model 222.
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