TRILOGY DC+ MODEL 2318L PULSE GENERATOR
FDA premarket approval P880086/S043 · decided 1997-12-29
Approval details
- PMA number
- P880086
- Supplement
- S043
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- TRILOGY DC+ MODEL 2318L PULSE GENERATOR
- Generic name
- implantable pacemaker Pulse-generator
- Applicant
- ABBOTT MEDICAL
- Date received
- 1997-12-08
- Decision date
- 1997-12-29
- Days to decision
- 21 days
- Decision code
- APPR
- Product code
- DXY
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Sylmar, CA
- Statement
- Approval for the APS III Model 3500 with Model 3302 Software Version 1.02.
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