Assurity, Assurity+, Endurity, Accent family of Pacemaker
FDA premarket approval P880086/S307 · decided 2019-12-23
Approval details
- PMA number
- P880086
- Supplement
- S307
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Assurity, Assurity+, Endurity, Accent family of Pacemaker
- Generic name
- implantable pacemaker Pulse-generator
- Applicant
- ABBOTT MEDICAL
- Date received
- 2019-10-30
- Decision date
- 2019-12-23
- Days to decision
- 54 days
- Decision code
- APPR
- Product code
- DXY
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Sylmar, CA
- Statement
- Approval for changes to Merlin PCS 3650 Programmer Model 3330 Software.
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