EVERA S DR ICD, EVERA S VR ICD, EVERA XT DR ICD AND EVERA XT VR ICD
FDA premarket approval P980016/S532 · decided 2015-03-11
Approval details
- PMA number
- P980016
- Supplement
- S532
- 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 AND EVERA XT VR ICD
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2015-02-18
- Decision date
- 2015-03-11
- Days to decision
- 21 days
- Decision code
- OK30
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- ADD NEW EQUIPMENT FOR THE FILL HOLE SEAL (FHS) AND BUTTON (BTN) WELDS WHICH ARE USED TO HERMETICALLY SEAL THE ELECTROLYTE FILL PORT.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.