Evera MRI XT DR SureScan ICD DDMB1D1, Evera MRI XT VR SureScan ICD DVMB1D1, Evera MRI S DR SureScan ICD DDMC3D1, Evera M
FDA premarket approval P980016/S607 · decided 2016-11-14
Approval details
- PMA number
- P980016
- Supplement
- S607
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Evera MRI XT DR SureScan ICD DDMB1D1, Evera MRI XT VR SureScan ICD DVMB1D1, Evera MRI S DR SureScan ICD DDMC3D1, Evera M
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2016-10-19
- Decision date
- 2016-11-14
- Days to decision
- 26 days
- Decision code
- OK30
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- Various previously accepted changes to align manufacturing of the Evera MRI and Visia AF DF-1 ICD device models with existing manufacturing, including, 1) Changes to the integrated circuit wafer manufacturing process; 2) an update to the distribution control sorter tool system; 3) updates to the post sterilization test; 4) a change to the suppliers cleaning process for the accelerometer; 5) changes to the wafer manufacturing process; 6) an update to the manufacturing inspection process for feedt
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