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SCULPTRA® (injectable poly-L Lactic acid)P030050

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SCULPTRA® (injectable poly-L Lactic acid) is a PLLA product, registered by Q-Med AB. Linked registrations: US P030050. First approved in US on 2004-08-03 (P030050). Data as of 2026-10-19.

  • Regulatory classPLLA · class not determined
  • HolderQ-Med AB
  • JurisdictionsUS
  • Updated2026-10-19 · v1

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

Registration and basics

SCULPTRA® (injectable poly-L Lactic acid)

Product
Regulatory class
Not determined (no verified registration linked)Could not verify
Category
PLLA
US · FDA PMA
P030050
Name on registration
SCULPTRA AND SCULPTRA AESTHETIC
Registrant
Q-Med AB
First approval
2004-08-03
This certificate issued
2004-08-03
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

    P030050 first approved

  2. US

    P030050 · P030050/S052

    30-Day Notice｜Process Change - Manufacturer/Sterilizer/Packager/Supplier｜to increase the sieving maximum batch size to 30kg for PLLA

  3. US

    P030050 · P030050/S051

    Normal 180 Day Track No User Fee｜Location Change - Manufacturer/Sterilizer/Packager/Supplier｜approval for an alternate sterilization manufac…

  4. US

    P030050 · P030050/S053

    30-Day Notice｜Process Change - Manufacturer/Sterilizer/Packager/Supplier｜to revamp Grade B, C and D clean rooms used for washing equipment/u…

  5. US

    P030050 · P030050/S054

    Real-Time Process｜Change Design/Components/Specifications/Material｜Approval to terminate elemental impurity testing for Sculptra vial stoppe…

  6. US

    P030050 · P030050/S055

    30-Day Notice｜Process Change - Manufacturer/Sterilizer/Packager/Supplier｜addition of a secondary autoclave for the sterilization of compound…

  7. US

    P030050 · P030050/S056

    30-Day Notice｜Process Change - Manufacturer/Sterilizer/Packager/Supplier｜Approval to modify compounding reactors R11 and R12 to be consisten…

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
  • P030050: 30-Day Notice｜Process Change - Manufacturer/Sterilizer/Packager/Supplier｜Approva…2026-09-17
  • P030050: 30-Day Notice｜Process Change - Manufacturer/Sterilizer/Packager/Supplier｜additio…2026-06-22
  • P030050: Real-Time Process｜Change Design/Components/Specifications/Material｜Approval to t…2026-04-15
  • P030050: 30-Day Notice｜Process Change - Manufacturer/Sterilizer/Packager/Supplier｜to reva…2024-11-13
  • P030050: Normal 180 Day Track No User Fee｜Location Change - Manufacturer/Sterilizer/Packa…2024-10-09

Sources

1