EVERA S DR/VR, EVERA XT DR/VR ICD'S; MAXIMO II ICD; PRTOECTA/PROTECTA XT ICD'S; SECURA ICD, VIRTUOSO II DR/VR ICD
FDA premarket approval P980016/S460 · decided 2014-02-27
Approval details
- PMA number
- P980016
- Supplement
- S460
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- EVERA S DR/VR, EVERA XT DR/VR ICD'S; MAXIMO II ICD; PRTOECTA/PROTECTA XT ICD'S; SECURA ICD, VIRTUOSO II DR/VR ICD
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2014-01-29
- Decision date
- 2014-02-27
- Days to decision
- 29 days
- Decision code
- OK30
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- AUTOMATED EQUIPMENT FOR THE VACUUM/BACKFILL AND LASER SEAM WELD PROCESS.
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