Evera: MRI DF-1 ICD, MRI ICD, S DR ICD, S VR ICD, XT DR ICD, XT VR ICD; Mirro MRI DR ICD, MRI VR ICD; Primo MRI DR ICD,
FDA premarket approval P980016/S699 · decided 2019-03-26
Approval details
- PMA number
- P980016
- Supplement
- S699
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Evera: MRI DF-1 ICD, MRI ICD, S DR ICD, S VR ICD, XT DR ICD, XT VR ICD; Mirro MRI DR ICD, MRI VR ICD; Primo MRI DR ICD,
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2019-02-25
- Decision date
- 2019-03-26
- Days to decision
- 29 days
- Decision code
- OK30
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- New external supplier for the dimer diamine for the Dadet epoxy.
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