RX5000 PROGRAMMER
FDA premarket approval P830026/S076 · decided 1999-10-29
Approval details
- PMA number
- P830026
- Supplement
- S076
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- RX5000 PROGRAMMER
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Applicant
- Boston Scientific
- Date received
- 1999-10-07
- Decision date
- 1999-10-29
- Days to decision
- 22 days
- Decision code
- APPR
- Product code
- LWP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- Approval for a modification to the as shipped configuration for refurbished and repaired Rx5000 Pacemaker Programmers. Specifically, to offer the Triangular Chest Lead Cable Model 526-04 as a purchasable accessory and no longer include it with the shipped units.
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