ENTRUST ICD, PROTECTA DF4 ICD, ICD, XT DF4 ICD, ICD, SECURA DF4 ICD, SECURA ICD, VIRTUOSO ICD VIRTUOSO II DR/VR ICD
FDA premarket approval P980016/S357 · decided 2013-03-26
Approval details
- PMA number
- P980016
- Supplement
- S357
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- ENTRUST ICD, PROTECTA DF4 ICD, ICD, XT DF4 ICD, ICD, SECURA DF4 ICD, SECURA ICD, VIRTUOSO ICD VIRTUOSO II DR/VR ICD
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2012-08-21
- Decision date
- 2013-03-26
- Days to decision
- 217 days
- Decision code
- APPR
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- APPROVAL FOR LABELING UPDATES TO INCORPORATE THE RESULTS OF THE RESPECT POST-APPROVAL STUDY FINAL REPORT, AND ADDITIONAL LABELING UPDATES.
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