DUAL CHAMBER, IMPLANTABLE PULSE GENERATOR
FDA premarket approval P820003/S091 · decided 2009-05-21
Approval details
- PMA number
- P820003
- Supplement
- S091
- 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
- 2009-03-02
- Decision date
- 2009-05-21
- Days to decision
- 80 days
- Decision code
- APPR
- Product code
- LWP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- APPROVAL FOR OPERATING SYSTEM MIGRATION FROM OS/2 TO XPE FOR THE 2090X CARELINK PROGRAMMER.
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