TRILOGY DC + PULSE GENERATOR, MODEL 2318L
FDA premarket approval P880086/S040 · decided 1997-01-10
Approval details
- PMA number
- P880086
- Supplement
- S040
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- TRILOGY DC + PULSE GENERATOR, MODEL 2318L
- Generic name
- implantable pacemaker Pulse-generator
- Applicant
- ABBOTT MEDICAL
- Date received
- 1996-11-08
- Decision date
- 1997-01-10
- Days to decision
- 63 days
- Decision code
- APPR
- Product code
- DXY
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Sylmar, CA
- Statement
- APPROVAL FOR THE TRILOGY DC+ MODEL 2318L PULSE GENERATOR WITH MODEL 3204A FUNCTION PACK FOR USE WITH THE APS II MODEL 30003 PROGRAMMER.
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