TRILOGY DR+ PULSE GENERATOR MODELS 2360L AND 2364L PULSE GENERATORS MODELS 2360L AND 2364L
FDA premarket approval P880086/S037 · decided 1997-06-30
Approval details
- PMA number
- P880086
- Supplement
- S037
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- TRILOGY DR+ PULSE GENERATOR MODELS 2360L AND 2364L PULSE GENERATORS MODELS 2360L AND 2364L
- Generic name
- implantable pacemaker Pulse-generator
- Applicant
- ABBOTT MEDICAL
- Date received
- 1996-08-01
- Decision date
- 1997-06-30
- Days to decision
- 333 days
- Decision code
- APPR
- Product code
- DXY
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Sylmar, CA
- Statement
- APPROVAL FOR THEMODEL 3250 APSU PROGRAMMER WITH MODEL 3263 SOFTWARE AND MODEL 3251 BASE STATION WITH MODEL 3265 SOFTWARE.
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