MEDTRONIC MODEL 5388 EXTERNAL PULSE GENERATOR (EPG)
FDA premarket approval P820003/S099 · decided 2010-12-16
Approval details
- PMA number
- P820003
- Supplement
- S099
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- MEDTRONIC MODEL 5388 EXTERNAL PULSE GENERATOR (EPG)
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2010-10-06
- Decision date
- 2010-12-16
- Days to decision
- 71 days
- Decision code
- APPR
- Product code
- LWP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- APPROVAL FOR THE REPLACEMENT OF THE SOCKET WITH SOLDERING OF THE EPROM ON THE MAIN BOARD FOR THE MODEL 5388 EXTERNAL PULSE GENERATOR (EPG).
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