DUAL CHAMBER, IMPLANTABLE PULSE GENERATOR
FDA premarket approval P820003/S104 · decided 2011-05-13
Approval details
- PMA number
- P820003
- Supplement
- S104
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- DUAL CHAMBER, IMPLANTABLE PULSE GENERATOR
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2011-01-04
- Decision date
- 2011-05-13
- Days to decision
- 129 days
- Decision code
- APPR
- Product code
- LWP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- APPROVAL FOR THE MEDTRONIC MODEL 9986 DESKTOP/ BOSS VERSION 2.4 FOR USE ON THE MEDTRONIC MODEL 2090 CARELINK PROGRAMMER.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.