SECURA DR/VR/VIRTUOSO II DR/VR/MAXIMO II DR/VR/ENTRUST/VIRTUOSO/MAXIMO/INTRINSIC/PROTECTA/PROTECTA XT
FDA premarket approval P980016/S300 · decided 2011-06-08
Approval details
- PMA number
- P980016
- Supplement
- S300
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- SECURA DR/VR/VIRTUOSO II DR/VR/MAXIMO II DR/VR/ENTRUST/VIRTUOSO/MAXIMO/INTRINSIC/PROTECTA/PROTECTA XT
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2011-05-09
- Decision date
- 2011-06-08
- Days to decision
- 30 days
- Decision code
- OK30
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- CHANGES TO THE NELIPAK SEALER MANUFACTURING PROCESS; INCLUDING ADDITION OF NEW EQUIPMENT, A CHANGE TO THE PROCESS RECIPE SPECIFICATION, AND THE IMPLEMENTATION OF A MONITORING TEST.
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