RX 7000 PROGRAMMING SYSTEM
FDA premarket approval P830026/S074 · decided 1999-02-18
Approval details
- PMA number
- P830026
- Supplement
- S074
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- RX 7000 PROGRAMMING SYSTEM
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Applicant
- Boston Scientific
- Date received
- 1998-10-09
- Decision date
- 1999-02-18
- Days to decision
- 132 days
- Decision code
- APPR
- Product code
- LWP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- Approval for Rx7000 Programming System Model 522-17 with R1.00.00 Software. The device, as modified, will be marketed under the trade name Rx7000 Model 522-17 Porgrammer and is indicated for the interrogation and programming of Sulzer Intermedics pulse generators.
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