EPG-SINGLE AND DUAL CHAMBER
FDA premarket approval P820003/S114 · decided 2011-12-21
Approval details
- PMA number
- P820003
- Supplement
- S114
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- EPG-SINGLE AND DUAL CHAMBER
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2011-11-25
- Decision date
- 2011-12-21
- Days to decision
- 26 days
- Decision code
- APPR
- Product code
- LWP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- APPROVAL FOR COMPONENTS CHANGING FROM LEAD-CONTAINING TO LEAD-FREE USED IN THE MEDTRONIC 2090 PROGRAMMER, 5388 DUAL CHAMBER EPG, AND 5348 SINGLE CHAMBER EPG.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.