EVERA MRI XT DR SURESCAN ICD, EVERA MRI XT VR SURESCAN ICD,EVERA MRI S DR SURESCAN ICD, EVERA MRI S VR SURESCAN ICD
FDA premarket approval P980016/S549 · decided 2015-10-14
Approval details
- PMA number
- P980016
- Supplement
- S549
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- EVERA MRI XT DR SURESCAN ICD, EVERA MRI XT VR SURESCAN ICD,EVERA MRI S DR SURESCAN ICD, EVERA MRI S VR SURESCAN ICD
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2015-09-15
- Decision date
- 2015-10-14
- Days to decision
- 29 days
- Decision code
- OK30
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- MANUFACTURING CHANGES: EXPANSION OF A CONTROLLED ENVIRONMENT AREA, ADDITION OF A LASER WELDING SYSTEM, UPDATE TO HYBRID TRACKING DURING MANUFACTURING, CONNECTOR MOLDING MANUFACTURING PROCESS CHANGE, ADDITION OF A SOAK OVEN TEMPERATURE VERIFICATION, AND IMPLEMENTATION OF A CONTINUOUS MONITORING SYSTEM.
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