VERSATRAX PACING SYSTEM
FDA premarket approval P820003/S123 · decided 2013-12-11
Approval details
- PMA number
- P820003
- Supplement
- S123
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- VERSATRAX PACING SYSTEM
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2013-07-10
- Decision date
- 2013-12-11
- Days to decision
- 154 days
- Decision code
- APPR
- Product code
- LWP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- APPROVAL FOR A MANUFACTURING SITE LOCATED AT TECHNICAL SERVICES FOR ELECTRONICS, INC., IN JACKSON, MINNESOTA.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.