EVERA MRI ICD,EVERA S DR ICD,EVERA S VR ICD,EVERA XT DR ICD,EVERA XT ICD,MAXIMO II ICD, PROTECTA ICD, PROTECT XT ICD,SEC
FDA premarket approval P980016/S552 · decided 2015-10-23
Approval details
- PMA number
- P980016
- Supplement
- S552
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- EVERA MRI ICD,EVERA S DR ICD,EVERA S VR ICD,EVERA XT DR ICD,EVERA XT ICD,MAXIMO II ICD, PROTECTA ICD, PROTECT XT ICD,SEC
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2015-09-30
- Decision date
- 2015-10-23
- Days to decision
- 23 days
- Decision code
- OK30
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- REMOVAL OF VARIOUS VISUAL INSPECTIONS AND RE-ORDERING OF STEPS IN THE WORK INSTRUCTIONS IMPLEMENTED IN THE AUTOMATIC LINE OF FINAL PACKAGING.
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