MEDTRONIC MODEL 5388 EXTERNAL PULSE GENERATOR
FDA premarket approval P820003/S100 · decided 2010-12-07
Approval details
- PMA number
- P820003
- Supplement
- S100
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- MEDTRONIC MODEL 5388 EXTERNAL PULSE GENERATOR
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2010-09-28
- Decision date
- 2010-12-07
- Days to decision
- 70 days
- Decision code
- APPR
- Product code
- LWP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- APPROVAL OF THE REWORK AND REFURBISH MANUFACTURING PROCESSES.
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