FDA Inspection
Boston Scientific Neuromodulation CorporationBoston Scientific Neuromodulation Corporation – FDA Inspection, Nov 17, 2016
Record Details
This FDA Inspection record concerns Boston Scientific Neuromodulation Corporation, with an inspection on November 17, 2016, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- November 17, 2016
- Product Type
- Devices
View Company Profile
ID · 185bc30c-e313-4adf-9355-0b1daba2df3a
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 994022
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
1- 21 CFR 803.50(a)(1)Report of Death or Serious Injury
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Boston Scientific Neuromodulation Corporation
9| Date | Classification | Office | Project area |
|---|---|---|---|
| April 8, 2026 | Not classified | Los Angeles District Office | Compliance: Devices |
| July 20, 2017 | Not classified | Los Angeles District Office | |
| January 22, 2016 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| July 29, 2015 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| April 25, 2013 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Boston Scientific Neuromodulation Corporation
- FDA Inspection 1276849 - 2026-04-08
- FDA Inspection 1034596 - 2017-07-20
- FDA Inspection 955462 - 2016-01-22
- FDA Inspection 936228 - 2015-07-29
- FDA Inspection 828898 - 2013-04-25
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