Merz North America, Inc.: PMA supplement approved for Belotero® Intense (+) Lidocaine
Merz North America, Inc. (Raleigh, North Carolina): PMA supplement approved for Belotero® Intense (+) Lidocaine. Dated 65 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: 2 related NC FdaApprovalPulse records and the 4-column CSV export.
| Field | Value |
|---|---|
| Sponsor | Merz North America, Inc. |
| Product | Belotero® Intense (+) Lidocaine |
| Generic / ingredient | Implant, dermal, for aesthetic use |
| Approval | PMA supplement (device change) |
| Application | P250016 S004 |
| Decided | 2026-08-31 |
| Panel / class | General, Plastic Surgery |
| Sponsor location | Raleigh, NC |
| Peer records CSV (3 NC 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: 2026-08-31
- Data refreshed: 2026-11-04
- Refunds on request within 14 days
Top FdaApprovalPulse records (NC first): Merz North America, Inc. · Merz North America, Inc. · Instylla, Inc. · Ventana Medical Systems, Inc. (Roche Tissue Diagnostics) · Cerenovus, Inc. · Browse all by state and category →
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: Merz North America, Inc. and 3 North Carolina peers
- North Carolina FdaApprovalPulse records like this one: 3
- Timing: Low: older than 30 days
- Estimated pipeline if you contact every North Carolina peer: $600 (peers × rate × deal size; an estimate from your assumptions, not a forecast)
30 / 100 Score
What is the FdaApprovalPulse record for Merz North America, Inc. in Raleigh, North Carolina?
The FDA approved Belotero® Intense (+) Lidocaine (P250016 S004) for Merz North America, Inc. on 2026-08-31: PMA supplement (device change).
How does Merz North America, Inc. compare to other North Carolina FdaApprovalPulse records?
It is 65 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.
Merz North America, Inc. vs. top 3 peers
| Organization | Location | Record date |
|---|---|---|
| Merz North America, Inc. | Raleigh, NC | 2026-08-31 |
| 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 North Carolina
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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.