TALENT AND BRIO PACEMAKERS
FDA premarket approval P950029/S015 · decided 2001-11-26
Approval details
- PMA number
- P950029
- Supplement
- S015
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- TALENT AND BRIO PACEMAKERS
- Generic name
- implantable pacemaker Pulse-generator
- Applicant
- MicroPort CRM USA, Inc.
- Date received
- 2001-10-31
- Decision date
- 2001-11-26
- Days to decision
- 26 days
- Decision code
- APPR
- Product code
- DXY
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Arlington, TN
- Statement
- APPROVAL TO CHANGE THE SILICONE HEADER CURRENTLY IN USE WITH THE SINGLE CHAMBER TALENT AND BRIO DEVICES TO TECOTHANE 75D POLYURETHANE HEADER (RIGID HEADER).
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