VERSATRAX PACING SYSTEM
FDA premarket approval P820003/S117 · decided 2013-05-30
Approval details
- PMA number
- P820003
- Supplement
- S117
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- VERSATRAX PACING SYSTEM
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2012-11-29
- Decision date
- 2013-05-30
- Days to decision
- 182 days
- Decision code
- APPR
- Product code
- LWP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- APPROVAL FOR THE IMPLEMENTATION OF A DF-4 LEAD COMPATIBLE, CRIMPABLE ALLIGATOR CLIP ONTO THE SURGICAL CABLES, PROCESS IMPROVEMENTS FOR THE SPLICE YOKE OF THE CABLES AND A CHANGE TO THE WIRE GAUGES USED IN THE 2292 CABLE ASSEMBLY.
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