Telemetry Wand
FDA premarket approval P110042/S179 · decided 2023-03-14
Approval details
- PMA number
- P110042
- Supplement
- S179
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Telemetry Wand
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Boston Scientific Corporation
- Date received
- 2023-01-23
- Decision date
- 2023-03-14
- Days to decision
- 50 days
- Decision code
- APPR
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- Approval for a manufacturing site located at Plexus Electronica S. de R.L. de C. V. Paseo del Norte No. 4640 Guadalajara Technology Park Zapopan, Jalisco 45010, Mexico for finished device manufacturing.
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