RX5000 PROGRAMMER
FDA premarket approval P830026/S075 · decided 1999-09-24
Approval details
- PMA number
- P830026
- Supplement
- S075
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Express GMP Supplement
- Trade name
- RX5000 PROGRAMMER
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Applicant
- Boston Scientific
- Date received
- 1999-09-07
- Decision date
- 1999-09-24
- Days to decision
- 17 days
- Decision code
- APPR
- Product code
- LWP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- Approval for a manufacturing site located at Benchmark Electronics, 4065 Theurer Blvd., Winona, MN 55987.
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