EVERA S DR,S VR XT DR, XT VE,ICD'S; MAXIMO II ICD,. PROTECTA ICD & XT ICD, SECURA ICD, VIRTUOSO II DR/VR ICD
FDA premarket approval P980016/S561 · decided 2016-02-05
Approval details
- PMA number
- P980016
- Supplement
- S561
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- EVERA S DR,S VR XT DR, XT VE,ICD'S; MAXIMO II ICD,. PROTECTA ICD & XT ICD, SECURA ICD, VIRTUOSO II DR/VR ICD
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2015-11-16
- Decision date
- 2016-02-05
- Days to decision
- 81 days
- Decision code
- APPR
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- Approval for the Alert Management Feature for the CareLink Network.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.