Boston Scientific Corp: PMA supplement approved for ROTAPRO Rotational Atherectomy Systems
Boston Scientific Corp (Maple Grove, Minnesota): PMA supplement approved for ROTAPRO Rotational Atherectomy Systems. Dated 15 days ago, it is in the active follow-up window. Score 60/100. 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: 60 related MN FdaApprovalPulse records and the 4-column CSV export.
| Field | Value |
|---|---|
| Sponsor | Boston Scientific Corp |
| Product | ROTAPRO Rotational Atherectomy Systems |
| Generic / ingredient | CATHETER, CORONARY, ATHERECTOMY |
| Approval | PMA supplement (device change) |
| Application | P900056 S226 |
| Decided | 2026-10-21 |
| Panel / class | Cardiovascular |
| Sponsor location | Maple Grove, MN |
| Peer records CSV (61 MN records) | 🔒 Click to unlock → |
| CRM-ready export with official source URLs | 🔒 Click to unlock → |
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CSV columns: Sponsor · Product · Approval · Decided · official source URL
- Source agency: openFDA device PMA and Drugs@FDA endpoints (U.S. Food and Drug Administration)
- Record date: 2026-10-21
- 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 Corp and 61 Minnesota peers
- Minnesota FdaApprovalPulse records like this one: 61
- Timing: Medium: dated in the last 30 days
- Estimated pipeline if you contact every Minnesota peer: $12,200 (peers × rate × deal size; an estimate from your assumptions, not a forecast)
60 / 100 Score
- Decided in the last 30 days.
What is the FdaApprovalPulse record for Boston Scientific Corp in Maple Grove, Minnesota?
The FDA approved ROTAPRO Rotational Atherectomy Systems (P900056 S226) for Boston Scientific Corp on 2026-10-21: PMA supplement (device change).
How does Boston Scientific Corp compare to other Minnesota FdaApprovalPulse records?
It is 15 days old, still within a typical 45-day follow-up window.
Boston Scientific Corp vs. top 3 peers
| Organization | Location | Record date |
|---|---|---|
| Boston Scientific Corp | Maple Grove, MN | 2026-10-21 |
| Instylla, Inc. | Bedford, MA | 2026-10-23 |
| Ventana Medical Systems, Inc. (Roche Tissue Diagnostics) | Tucson, AZ | 2026-10-23 |
| Cerenovus, Inc. | Miami, FL | 2026-10-23 |
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FdaApprovalPulse: PMA supplement (device change) FdaApprovalPulse: records in Minnesota
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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.