DUAL CHAMBER, IMPLANTABLE PULSE GENERATOR
FDA premarket approval P820003/S092 · decided 2009-07-28
Approval details
- PMA number
- P820003
- Supplement
- S092
- Supplement type
- Real-Time Process
- 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
- 2009-06-17
- Decision date
- 2009-07-28
- Days to decision
- 41 days
- Decision code
- APPR
- Product code
- LWP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- APPROVAL FOR VERSION 2.2 OF THE MODEL 9986 DESKTOP/BOSS SOFTWARE FOR THE MEDTRONIC 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.