EVERA S DR .S VR, XT DR, XT VR ICD'S, MAXIMO II ICD, PROTECTA ICD, PROTECTA XT ICD, SECURA ICD, VIRTUOSO II DR/VR ICD
FDA premarket approval P980016/S546 · decided 2015-09-09
Approval details
- PMA number
- P980016
- Supplement
- S546
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- EVERA S DR .S VR, XT DR, XT VR ICD'S, MAXIMO II ICD, PROTECTA ICD, PROTECTA XT ICD, SECURA ICD, VIRTUOSO II DR/VR ICD
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2015-08-11
- Decision date
- 2015-09-09
- Days to decision
- 29 days
- Decision code
- OK30
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- NEW CONTINUOUS MONITORING SYSTEM FOR THE MANUFACTURING AREA AT A FINAL DEVICE MANUFACTURING FACILITY.
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