Promote/+/RF/Q, PROMOTE ACCEL, PROMOTE QUADRA, UNIFY,UNIFY ASSURA, UNIFY QUADRA
FDA premarket approval P030054/S316 · decided 2017-01-31
Approval details
- PMA number
- P030054
- Supplement
- S316
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Promote/+/RF/Q, PROMOTE ACCEL, PROMOTE QUADRA, UNIFY,UNIFY ASSURA, UNIFY QUADRA
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Applicant
- ABBOTT MEDICAL
- Date received
- 2016-12-14
- Decision date
- 2017-01-31
- Days to decision
- 48 days
- Decision code
- APPR
- Product code
- NIK
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Sylmar, CA
- Statement
- Approval for software updates to the Merlin@home v8.2.2 to increase the cybersecurity of the system.
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