SECURA DR/VR/MAXIMO II DR/VR/VIRTUOSO II DR/VR/VIRTUOSO ICD
FDA premarket approval P980016/S260 · decided 2010-10-15
Approval details
- PMA number
- P980016
- Supplement
- S260
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- SECURA DR/VR/MAXIMO II DR/VR/VIRTUOSO II DR/VR/VIRTUOSO ICD
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2010-09-16
- Decision date
- 2010-10-15
- Days to decision
- 29 days
- Decision code
- OK30
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- ADDITION OF A SECOND SUPPLIER FOR THE BPA COMPONENT AND A CHANGE IN THE COMPONENT INSPECTION PROCESS.
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