EVERA S DR ICD, EVERA S VR ICD, EVERA XT DR ICD, EVERA XT VR ICD
FDA premarket approval P980016/S465 · decided 2014-03-07
Approval details
- PMA number
- P980016
- Supplement
- S465
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- EVERA S DR ICD, EVERA S VR ICD, EVERA XT DR ICD, EVERA XT VR ICD
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2014-02-18
- Decision date
- 2014-03-07
- Days to decision
- 17 days
- Decision code
- OK30
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- CHANGE IN THE PROCESSING AID USED IN POLYTETRAFLUORO-ETHYLENE (PTFE) PRODUCTION AT A SUPPLIER.
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