MODELS 5348 AND 5388 EXTERNAL PULSE GENERATORS
FDA premarket approval P820003/S081 · decided 2007-09-28
Approval details
- PMA number
- P820003
- Supplement
- S081
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- MODELS 5348 AND 5388 EXTERNAL PULSE GENERATORS
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2007-07-19
- Decision date
- 2007-09-28
- Days to decision
- 71 days
- Decision code
- APPR
- Product code
- LWP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- APPROVAL FOR MINOR DESIGN CHANGES AND INTERNAL COMPONENT UPDATES TO MEDTRONIC MODEL 5348 AND MODEL 5388 EXTERNAL PULSE GENERATORS.
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