RX5000 (TM) GRAPHICS PROGRAMMER
FDA premarket approval P830026/S070 · decided 1997-04-17
Approval details
- PMA number
- P830026
- Supplement
- S070
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- RX5000 (TM) GRAPHICS PROGRAMMER
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Applicant
- Boston Scientific
- Date received
- 1997-03-14
- Decision date
- 1997-04-17
- Days to decision
- 34 days
- Decision code
- APPR
- Product code
- LWP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- APPROVAL FOR THE RX5000 MODEL 522-12 VERSION 2.01.03 OPERATING SYSTEM.
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