MEDTRONIC MODEL 5388 & 5348 EXTERNAL PULSE GENERATOR
FDA premarket approval P820003/S085 · decided 2008-10-17
Approval details
- PMA number
- P820003
- Supplement
- S085
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- MEDTRONIC MODEL 5388 & 5348 EXTERNAL PULSE GENERATOR
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2008-08-27
- Decision date
- 2008-10-17
- Days to decision
- 51 days
- Decision code
- APPR
- Product code
- LWP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- APPROVAL FOR A MANUFACTURING SITE LOCATED AT BENCHMARK ELECTRONICS, INC., WINONA, MINNESOTA.
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