RX222 MODEL 522-10 POCKET PROGRAMMER
FDA premarket approval P830026/S057 · decided 1993-03-03
Approval details
- PMA number
- P830026
- Supplement
- S057
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- RX222 MODEL 522-10 POCKET PROGRAMMER
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Applicant
- Boston Scientific
- Date received
- 1992-08-05
- Decision date
- 1993-03-03
- Days to decision
- 210 days
- Decision code
- APPR
- Product code
- LWP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
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