MODEL 5441 EPG PLASTIC COVER
FDA premarket approval P820003/S088 · decided 2009-02-11
Approval details
- PMA number
- P820003
- Supplement
- S088
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- MODEL 5441 EPG PLASTIC COVER
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2009-01-12
- Decision date
- 2009-02-11
- Days to decision
- 30 days
- Decision code
- OK30
- Product code
- LWP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- TRANSFERRING OF THE FINAL IN-PROCESS INSPECTION AND FINAL PACKAGE PROCESS STEPS FROM MEDTRONIC RICE CREEK FACILITY TO THE CONTRACT MANUFACTURER.
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