TALENT MODEL 213 DUAL-CHAMBER, DUAL SENSOR, IMPLANTABLE CARDIAC PACEMAKER, ELA MEDICAL PROGRAMMER
FDA premarket approval P950029/S006 · decided 2000-05-18
Approval details
- PMA number
- P950029
- Supplement
- S006
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- TALENT MODEL 213 DUAL-CHAMBER, DUAL SENSOR, IMPLANTABLE CARDIAC PACEMAKER, ELA MEDICAL PROGRAMMER
- Generic name
- implantable pacemaker Pulse-generator
- Applicant
- MicroPort CRM USA, Inc.
- Date received
- 1999-08-23
- Decision date
- 2000-05-18
- Days to decision
- 269 days
- Decision code
- APPR
- Product code
- DXY
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Arlington, TN
- Statement
- Approval for the introduction of Talent Rate Responsive Pacemaker Models DR213, DR223, and SR113; the Optus G Rate Responsive Pacemaker Models 4621 and 4624; and the CSO 4.12 Programming Software.
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