ENTRUST/INTRINSIC/MARQUIS/MAXIMO/MAXIMO II/PROTECTO/PROTECTO XT/SECURA/VIRTUOSO/VIRTUOSO II/PROTECTA XT DR/PROTECTA DR
FDA premarket approval P980016/S331 · decided 2013-02-28
Approval details
- PMA number
- P980016
- Supplement
- S331
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- ENTRUST/INTRINSIC/MARQUIS/MAXIMO/MAXIMO II/PROTECTO/PROTECTO XT/SECURA/VIRTUOSO/VIRTUOSO II/PROTECTA XT DR/PROTECTA DR
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2011-11-21
- Decision date
- 2013-02-28
- Days to decision
- 465 days
- Decision code
- APPR
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- APPROVAL FOR THE MODEL 080118 MEDICAL ADHESIVE USED AS AN ACCESSORY FOR THE ENTRUST, INTRINSIC, MARQUIS, MAXIMO, MAXIMO II, PROTECTA, PROTECTA XT, SECURA, VIRTUOSO, VIRTUOSO II, PROTECTA XT DR, AND PROTECTA DR ICDS.
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