TRILOGY SR+ MODEL 2260L & 2264L CARDIAC PULSE GENERATORS WITH THE MODEL 3023 PDX FUNCTION PACK
FDA premarket approval P880086/S039 · decided 1997-03-12
Approval details
- PMA number
- P880086
- Supplement
- S039
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- TRILOGY SR+ MODEL 2260L & 2264L CARDIAC PULSE GENERATORS WITH THE MODEL 3023 PDX FUNCTION PACK
- Generic name
- implantable pacemaker Pulse-generator
- Applicant
- ABBOTT MEDICAL
- Date received
- 1996-08-14
- Decision date
- 1997-03-12
- Days to decision
- 210 days
- Decision code
- APPR
- Product code
- DXY
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Sylmar, CA
- Statement
- APPROVAL FOR THE TRILOGY SR+ MODEL 2260L AND 2264L CARDIAC PULSE GENERATORS WITHT HE MODEL 3023 PD(X) FUNCTION PACK
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