ASSURITY, ASSURITY+, ENDURITY, ACCENT FAMILY OF PACEMAKERS
FDA premarket approval P880086/S273 · decided 2016-07-25
Approval details
- PMA number
- P880086
- Supplement
- S273
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- ASSURITY, ASSURITY+, ENDURITY, ACCENT FAMILY OF PACEMAKERS
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Applicant
- ABBOTT MEDICAL
- Date received
- 2016-04-26
- Decision date
- 2016-07-25
- Days to decision
- 90 days
- Decision code
- APPR
- Product code
- LWP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Sylmar, CA
- Statement
- Approval for software modifications to the Merlin.net MN6000 HF Web Application v9.0 software.
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