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RADIESSE® Injectable ImplantP050052

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RADIESSE® Injectable Implant is a Other product, registered by Merz North America, Inc.. Linked registrations: US P050052. First approved in US on 2006-12-22 (P050052). Data as of 2026-10-19.

  • Regulatory classOther · class not determined
  • HolderMerz North America, Inc.
  • JurisdictionsUS
  • Updated2026-10-19 · v1

Registration and basics are public; findings and prices need an account

Registration and basics

RADIESSE® Injectable Implant

Product
Regulatory class
Not determined (no verified registration linked)Could not verify
Category
Other
US · FDA PMA
P050052
Name on registration
RADIESSE INJECTABLE IMPLANT
Registrant
Merz North America, Inc.
First approval
2006-12-22
This certificate issued
2006-12-22
Checked against official page
Not yet checked field by field against the live official page

Public: fields from the registration record.

Label facts by jurisdiction

What each jurisdiction's label says for the same attribute; gaps are marked Not reported, irrelevant ones N/A

No data yet

Registration timeline

  1. US

    P050052 first approved

  2. US

    P050052 · P050052/S175

    30-Day Notice｜Process Change - Manufacturer/Sterilizer/Packager/Supplier｜the implementation of a new, alternate, GMP Equipment Washer to inc…

  3. US

    P050052 · P050052/S177

    30-Day Notice｜Process Change - Manufacturer/Sterilizer/Packager/Supplier｜Approval for implementation of a conical dryer in the manufacture o…

  4. US

    P050052 · P050052/S176

    30-Day Notice｜Process Change - Manufacturer/Sterilizer/Packager/Supplier｜Approval for implementation of a Green Sieve System used in the man…

  5. US

    P050052 · P050052/S162

    Panel Track｜Labeling Change - Indications/instructions/shelf life/tradename｜Approval for expanding the indications of Radiesse Injectable Im…

  6. US

    P050052 · P050052/S178

    30-Day Notice｜Process Change - Manufacturer/Sterilizer/Packager/Supplier｜installation and qualification of a new microscope in the Quality L…

  7. US

    P050052 · P050052/S179

    30-Day Notice｜Process Change - Manufacturer/Sterilizer/Packager/Supplier｜modification of the Dynamic Crossflow Filtration (DCF) System for u…

First approval, this certificate's issue date (updated after renewals or changes), changes and expiry are listed separately; a missing first approval means it was not obtained from an official source. Up to 6 recent changes per registration; click the number for the full record.

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Recent changes

5
  • P050052: 30-Day Notice｜Process Change - Manufacturer/Sterilizer/Packager/Supplier｜modific…2026-06-26
  • P050052: 30-Day Notice｜Process Change - Manufacturer/Sterilizer/Packager/Supplier｜install…2026-05-14
  • P050052: Panel Track｜Labeling Change - Indications/instructions/shelf life/tradename｜Appr…2026-03-31
  • P050052: 30-Day Notice｜Process Change - Manufacturer/Sterilizer/Packager/Supplier｜Approva…2026-03-24
  • P050052: 30-Day Notice｜Process Change - Manufacturer/Sterilizer/Packager/Supplier｜Approva…2026-03-24

Sources

1