VARIOUS TEMPORARY PACEMAKER MODELS
FDA premarket approval P820003/S086 · decided 2009-03-09
Approval details
- PMA number
- P820003
- Supplement
- S086
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- VARIOUS TEMPORARY PACEMAKER MODELS
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2008-09-23
- Decision date
- 2009-03-09
- Days to decision
- 167 days
- Decision code
- APPR
- Product code
- LWP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- APPROVAL FOR A CHANGE IN THE MODEL 5433 CABLE INSPECTION LEVEL.
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