EXTERNAL PULSE GENERATOR
FDA premarket approval P820003/S084 · decided 2008-11-21
Approval details
- PMA number
- P820003
- Supplement
- S084
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- EXTERNAL PULSE GENERATOR
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2008-07-28
- Decision date
- 2008-11-21
- Days to decision
- 116 days
- Decision code
- APPR
- Product code
- LWP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- APPROVAL FOR COMPONENT, DESIGN, MANUFACTURING PROCESS, AND LABELING UPDATES TO THE MEDTRONIC 2090 CARELINK PROGRAMMER, WHICH ARE DRIVEN BY COMPONENT OBSOLESCENCE. UPDATES INCLUDE A NEW TOUCH SCREEN, A NEW LIQUID CRYSTAL DISPLAY (LCD), A LOCAL AREA NETWORK (LAN) ON THE MICRO-PROCESSING UNIT (MPU), NEW HARD DRIVES, UPDATES TO THE LINK ELECTRONICS MODULE (LEM), AND OTHER MINOR CHANGES TO ADDRESS OBSOLETE COMPONENTS.
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