VARIOUS FAMILIES OF PACEMAKERS
FDA premarket approval P820003/S082 · decided 2008-05-09
Approval details
- PMA number
- P820003
- Supplement
- S082
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- VARIOUS FAMILIES OF PACEMAKERS
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2007-09-28
- Decision date
- 2008-05-09
- Days to decision
- 224 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.
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