MODEL 2490A CARELINK MONITOR AND DEVICE DATA MANAGEMENT APPLICATION (DDMA) SOFTWARE MODEL 2491 VERSION 1.0
FDA premarket approval P980016/S028 · decided 2002-04-16
Approval details
- PMA number
- P980016
- Supplement
- S028
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- MODEL 2490A CARELINK MONITOR AND DEVICE DATA MANAGEMENT APPLICATION (DDMA) SOFTWARE MODEL 2491 VERSION 1.0
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2002-03-27
- Decision date
- 2002-04-16
- Days to decision
- 20 days
- Decision code
- APPR
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- APPROVAL FOR EXPANSION OF THE FUNCTIONALITY OF THE MODEL 2490A CARELINK MONITOR AND MODEL 2491 SOFTWARE, VERSION 1.0 TO INCLUDE THE GEM, GEM DR, GEM II VR, GEM II DR, GEM III VR AND GEM III DR IMPLANTABLE CARDIOVERTER DEFIBRILLATORS.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.