Merz North America, Inc.: PMA supplement approved for Belotero Balance Dermal Filler; Belotero Balance (+) Lidocaine
Merz North America, Inc. (Franksville, Wisconsin): PMA supplement approved for Belotero Balance Dermal Filler; Belotero Balance (+) Lidocaine. Dated 185 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: 4 related WI FdaApprovalPulse records and the 4-column CSV export.
| Field | Value |
|---|---|
| Sponsor | Merz North America, Inc. |
| Product | Belotero Balance Dermal Filler; Belotero Balance (+) Lidocaine |
| Generic / ingredient | Implant, dermal, for aesthetic use |
| Approval | PMA supplement (device change) |
| Application | P090016 S067 |
| Decided | 2026-05-03 |
| Panel / class | General, Plastic Surgery |
| Sponsor location | Franksville, WI |
| Peer records CSV (5 WI records) | 🔒 Click to unlock → |
| CRM-ready export with official source URLs | 🔒 Click to unlock → |
Watch Merz North America, Inc.
Free email alert. Alert me when this company gets a new filing, lien, permit, contract or expiry in this feed. One confirmation email; unsubscribe any time.
Free for 1 company. More companies from $9/mo (25), $49/mo (500 + CSV), $199/mo (500 + CSV + API). Cancel any time from the link in every email.
Unlock Merz North America + all 5 WI records (CSV)
Instant CSV download · Card, Apple Pay, Google Pay or Link via Stripe · No account required
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: 2026-05-03
- Data refreshed: 2026-11-04
- Refunds on request within 14 days
Top FdaApprovalPulse records (WI first): Promega Corporation · Exact Sciences Corporation · Exact Sciences Corporation · Exact Sciences Corporation · Instylla, 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
Is this your business? Add a "Listed on Zalwin" badge to your site
Paste this snippet into your website. It links to this public record; nothing is tracked on your site.
Peer benchmark and outreach value: Merz North America, Inc. and 5 Wisconsin peers
- Wisconsin FdaApprovalPulse records like this one: 5
- Timing: Low: older than 30 days
- Estimated pipeline if you contact every Wisconsin peer: $1,000 (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 Franksville, Wisconsin?
The FDA approved Belotero Balance Dermal Filler; Belotero Balance (+) Lidocaine (P090016 S067) for Merz North America, Inc. on 2026-05-03: PMA supplement (device change).
How does Merz North America, Inc. compare to other Wisconsin FdaApprovalPulse records?
It is 185 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. | Franksville, WI | 2026-05-03 |
| 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 |
Related records
FdaApprovalPulse: PMA supplement (device change) FdaApprovalPulse: records in Wisconsin
More Wisconsin public-record feeds
New Executive & Auditor Changes (SEC 8-K) in Wisconsin HIPAA Breach Reports (500+ Individuals) by State & Type in Wisconsin Newly Posted IRS Automatic Revocations of Tax Exemption in Wisconsin Excluded Health Care Business Search (OIG LEIE) in Wisconsin Nursing Home Inspection Deficiencies by State & Severity in Wisconsin New, Terminating & Large 401(k) Plans from Form 5500 Filings in Wisconsin Newly CLIA-Certified Laboratories by State & Certificate in Wisconsin Largest U.S. Greenhouse Gas Emitters by Company, Sector & State (EPA GHGRP) in Wisconsin
How to monitor Merz North America, Inc. and peer pma supplement (device change) records
Get new FdaApprovalPulse records like Merz North America, Inc. by email (free, weekly)
We email one confirmation link now; the weekly digest starts only after you confirm. One-click unsubscribe in every email.
Double opt-in: nothing is sent until you click the confirmation link. One-click unsubscribe.
Get new approvals in your categories
FdaApprovalPulse emails new device and drug approvals matching your approval types.
✓ Read-only, live public data · Key and unlock right after payment · Card, Apple Pay, Google Pay or Link via Stripe · Refunds on request within 14 days
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.