SJM MRI Activator
FDA premarket approval P140033/S012 · decided 2017-10-30
Approval details
- PMA number
- P140033
- Supplement
- S012
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- SJM MRI Activator
- Generic name
- implantable pacemaker Pulse-generator
- Applicant
- ABBOTT MEDICAL
- Date received
- 2017-08-01
- Decision date
- 2017-10-30
- Days to decision
- 90 days
- Decision code
- APPR
- Product code
- DXY
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Sylmar, CA
- Statement
- Approval for the Model EX4001 SJM MRI Activator.
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