INTEGRITY AFX DR (MODEL 5342) & SR (MODEL 5142) PULSE GENERATORS
FDA premarket approval P880086/S070 · decided 2000-04-06
Approval details
- PMA number
- P880086
- Supplement
- S070
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- INTEGRITY AFX DR (MODEL 5342) & SR (MODEL 5142) PULSE GENERATORS
- Generic name
- implantable pacemaker Pulse-generator
- Applicant
- ABBOTT MEDICAL
- Date received
- 2000-03-13
- Decision date
- 2000-04-06
- Days to decision
- 24 days
- Decision code
- APPR
- Product code
- DXY
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Sylmar, CA
- Statement
- Approval for the Integrity Afx DR Model and SR Model 5142.
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