ENTRUST ICD, INTRINSIC 30ICD, MARQUIS DR ICD, VR ICD, MAXIMO DR ICD, VR ICD, EVERA S DR ICD, S VR ICD,XT VR ICD, MAXIMO
FDA premarket approval P980016/S436 · decided 2014-02-14
Approval details
- PMA number
- P980016
- Supplement
- S436
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- ENTRUST ICD, INTRINSIC 30ICD, MARQUIS DR ICD, VR ICD, MAXIMO DR ICD, VR ICD, EVERA S DR ICD, S VR ICD,XT VR ICD, MAXIMO
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2013-08-23
- Decision date
- 2014-02-14
- Days to decision
- 175 days
- Decision code
- APPR
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- APPROVAL FOR UPDATES TO THE MEDTRONIC MYCARELINK PATIENT MONITOR MODEL24950, READER MODEL 24955, AND ACCESSORIES, MODEL 2491 DEVICE DATA MANAGEMENT APPLICATION (DDMA) AND APPLICATION SOFTWARE SW026 TO SUPPORT MEDTRONIC¿S REVEAL LINQ INSERTABLE CARDIAC MONITORS (ICM).
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.