Assurity, Assurity+, Endurity, Accent family of Pacemakers
FDA premarket approval P880086/S308 · decided 2020-06-30
Approval details
- PMA number
- P880086
- Supplement
- S308
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Assurity, Assurity+, Endurity, Accent family of Pacemakers
- Generic name
- implantable pacemaker Pulse-generator
- Applicant
- ABBOTT MEDICAL
- Date received
- 2019-11-08
- Decision date
- 2020-06-30
- Days to decision
- 235 days
- Decision code
- APPR
- Product code
- DXY
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Sylmar, CA
- Statement
- Approval for Avant, Neutrino NxT, Gallant, and Entrant families of ICDs and CRT-Ds; myMerlinPulse mobile application; Merlin PCS 3650 Programmer Software Model 3330 v25.0.1; and Merlin.net MN5000 v7.8.
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