MARQUIS/MAXIMO ICD/INTRINSIC ICD/CAPSURE LEAD/ENTRUST ICD/VIRTUOSO ICD/MAXIMO II ICD/SECURA ICD/VIRTUOSO II ICD
FDA premarket approval P980016/S288 · decided 2011-06-27
Approval details
- PMA number
- P980016
- Supplement
- S288
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- MARQUIS/MAXIMO ICD/INTRINSIC ICD/CAPSURE LEAD/ENTRUST ICD/VIRTUOSO ICD/MAXIMO II ICD/SECURA ICD/VIRTUOSO II ICD
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2011-03-22
- Decision date
- 2011-06-27
- Days to decision
- 97 days
- Decision code
- APPR
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- APPROVAL FOR THE CHANGE OF THE CLEANING CONTROL AREA AND THE ASSOCIATED PROCESSES.
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