Boston Scientific Corporation: PMA supplement approved for TheraSphere
Boston Scientific Corporation (Marborough, Massachusetts): PMA supplement approved for TheraSphere. Dated 75 days ago, it serves as a historical benchmark. Score 30/100. As of 2026-11-04, from openFDA device PMA and Drugs@FDA endpoints (U.S. Food and Drug Administration).
Data as of · Compiled by Zalwin from openFDA device PMA and Drugs@FDA endpoints (U.S. Food and Drug Administration)
Free preview: all 8 published fields of this record are shown below. Locked: 36 related MA FdaApprovalPulse records and the 4-column CSV export.
| Field | Value |
|---|---|
| Sponsor | Boston Scientific Corporation |
| Product | TheraSphere |
| Generic / ingredient | Microspheres radionuclide |
| Approval | PMA supplement (device change) |
| Application | P200029 S014 |
| Decided | 2026-08-21 |
| Panel / class | Radiology |
| Sponsor location | Marborough, MA |
| Peer records CSV (37 MA records) | 🔒 Click to unlock → |
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- Source agency: openFDA device PMA and Drugs@FDA endpoints (U.S. Food and Drug Administration)
- Record date: 2026-08-21
- Data refreshed: 2026-11-04
- Refunds on request within 14 days
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LIVE PUBLIC DATA Source: openFDA device PMA and Drugs@FDA endpoints (U.S. Food and Drug Administration) · Last refreshed: Wed, 04 Nov 2026 06:06:18 GMT
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Peer benchmark and outreach value: Boston Scientific Corporation and 37 Massachusetts peers
- Massachusetts FdaApprovalPulse records like this one: 37
- Timing: Low: older than 30 days
- Estimated pipeline if you contact every Massachusetts peer: $7,400 (peers × rate × deal size; an estimate from your assumptions, not a forecast)
30 / 100 Score
What is the FdaApprovalPulse record for Boston Scientific Corporation in Marborough, Massachusetts?
The FDA approved TheraSphere (P200029 S014) for Boston Scientific Corporation on 2026-08-21: PMA supplement (device change).
How does Boston Scientific Corporation compare to other Massachusetts FdaApprovalPulse records?
It is 75 days old; check the official source for later updates before acting. Its Score of 30/100 is modest; treat it as background rather than a priority.
Boston Scientific Corporation vs. top 3 peers
| Organization | Location | Record date |
|---|---|---|
| Boston Scientific Corporation | Marborough, MA | 2026-08-21 |
| Instylla, Inc. | Bedford, MA | 2026-10-23 |
| Instylla, Inc. | Bedford, MA | 2026-10-23 |
| Instylla, Inc. | Bedford, MA | 2026-10-21 |
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From openFDA (PMA and Drugs@FDA). openFDA can lag FDA decisions by days to weeks. Drug supplement types follow the FDA submission class (labeling and REMS, manufacturing/CMC, efficacy, other). Company and product level only. Verify on FDA databases before relying on an approval.