VERSATRAX IPG
FDA premarket approval P820003/S133 · decided 2015-04-02
Approval details
- PMA number
- P820003
- Supplement
- S133
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- VERSATRAX IPG
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2015-03-27
- Decision date
- 2015-04-02
- Days to decision
- 6 days
- Decision code
- OK30
- Product code
- LWP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- ACCEPTANCE OF A NEW DOSIMETRY SYSTEM AT THE LIBERTYVILLE, IL LOCATION.
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