RX5000 PROGRAMMER MODEL 522-12
FDA premarket approval P830026/S065 · decided 1996-05-30
Approval details
- PMA number
- P830026
- Supplement
- S065
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- RX5000 PROGRAMMER MODEL 522-12
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Applicant
- Boston Scientific
- Date received
- 1995-12-12
- Decision date
- 1996-05-30
- Days to decision
- 170 days
- Decision code
- APPR
- Product code
- LWP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- APPROVAL FOR ALTERNATE COMPPONENTS FOR THE RX5000 PROGRAMMER
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