EVERA S DR, EVERA S VR, EVERA XT DR
FDA premarket approval P980016/S409 · decided 2013-05-03
Approval details
- PMA number
- P980016
- Supplement
- S409
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- EVERA S DR, EVERA S VR, EVERA XT DR
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2013-04-08
- Decision date
- 2013-05-03
- Days to decision
- 25 days
- Decision code
- OK30
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- THE IMPLEMENTATION OF FACTORY WORKS RELEASE 8.0 AND MES WEB SERVICES RELEASE 2.1; 2) THE APPROVAL OF MANUFACTURING LINES IN A NEW EXTENSION OF A CONTROLLED ENVIRONMENT AREA; 3) NEW PRESSURE TEST EQUIPMENT TO VERIFY HERMETICITY; 4) MODIFICATIONS TO A CONTROLLED ENVIRONMENT; 5) A CHANGE TO THE DESCUM AND CLEANING PROCESS FOR THE 3UM CMOS INTEGRATED CIRCUIT; AND 6) A NEW SOFTWARE VERSION FOR PROCESS DATA COLLECTION SOFTWARE AT A MEDTRONIC SUPPLIER.
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