TALENT AND BRIO PACEMAKERS (RIGID CONNECTOR)
FDA premarket approval P950029/S010 · decided 2000-10-10
Approval details
- PMA number
- P950029
- Supplement
- S010
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- TALENT AND BRIO PACEMAKERS (RIGID CONNECTOR)
- Generic name
- implantable pacemaker Pulse-generator
- Applicant
- MicroPort CRM USA, Inc.
- Date received
- 2000-09-27
- Decision date
- 2000-10-10
- Days to decision
- 13 days
- Decision code
- APPR
- Product code
- DXY
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Arlington, TN
- Statement
- APPROVAL TO CHANGE THE HEADER MATERIAL IN THE TALENT AND BRIO PACEMAKERS FROM SILICONE RUBBER TO TECOTHANE 75D POLYURETHANE
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