External Paulse Generator (EPG) Patient Cable
FDA premarket approval P820003/S143 · decided 2024-02-27
Approval details
- PMA number
- P820003
- Supplement
- S143
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- External Paulse Generator (EPG) Patient Cable
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2024-01-29
- Decision date
- 2024-02-27
- Days to decision
- 29 days
- Decision code
- OK30
- Product code
- LWP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- a new sterilization dose establishment method, VDmax 35, and update bioburden limits
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