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PREVELLE SILKP030032

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PREVELLE SILK is a Hyaluronic acid filler product, registered by Genzyme Biosurgery. Linked registrations: US P030032. First approved in US on 2004-04-22 (P030032). Data as of 2026-10-19.

  • Regulatory classHyaluronic acid filler · class not determined
  • HolderGenzyme Biosurgery
  • JurisdictionsUS
  • Updated2026-10-19 · v1

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

Registration and basics

PREVELLE SILK

Product
Regulatory class
Not determined (no verified registration linked)Could not verify
Category
Hyaluronic acid filler
US · FDA PMA
P030032 (cancelled)
Name on registration
HYLAFORM (HYLAN B GEL)
Registrant
Genzyme Biosurgery
First approval
2004-04-22
This certificate issued
2004-04-22
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

    P030032 first approved

  2. US

    P030032 · P030032/S010

    135 Review Track For 30-Day Notice｜Process Change - Manufacturer/Sterilizer/Packager/Supplier｜P940015/S0199/15/10135-DAY SYNVISC/SYNVISC-ONE…

  3. US

    P030032 · P030032/S012

    Real-Time Process｜Change Design/Components/Specifications/Material｜APPROVAL FOR CHANGES IN THE METHODS AND SPECIFICATIONS FOR TESTING THE PR…

  4. US

    P030032 · P030032/S013

    30-Day Notice｜Process Change - Manufacturer/Sterilizer/Packager/Supplier｜ADDITION OF A RAW MATERIAL IDENTIFICATION SYSTEM AND AN AUTOMATED F…

  5. US

    P030032 · P030032/S014

    135 Review Track For 30-Day Notice｜Process Change - Manufacturer/Sterilizer/Packager/Supplier｜APPROVAL FOR THE ADDITION OF A NEW PRODUCT DAT…

  6. US

    P030032 · P030032/S016

    135 Review Track For 30-Day Notice｜Process Change - Manufacturer/Sterilizer/Packager/Supplier｜APPROVAL FOR CHANGES TO THE QUALITY CONTROL TE…

  7. US

    P030032 · P030032/S017

    30-Day Notice｜Process Change - Manufacturer/Sterilizer/Packager/Supplier｜ADDITION OF ENDOTOXIN TESTING TO THE PURIFIED WATER RAW MATERIAL SP…

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
  • P030032: 30-Day Notice｜Process Change - Manufacturer/Sterilizer/Packager/Supplier｜ADDITIO…2014-09-05
  • P030032: 135 Review Track For 30-Day Notice｜Process Change - Manufacturer/Sterilizer/Pack…2014-08-06
  • P030032: 135 Review Track For 30-Day Notice｜Process Change - Manufacturer/Sterilizer/Pack…2012-05-03
  • P030032: 30-Day Notice｜Process Change - Manufacturer/Sterilizer/Packager/Supplier｜ADDITIO…2011-10-07
  • P030032: Real-Time Process｜Change Design/Components/Specifications/Material｜APPROVAL FOR …2011-07-18

Sources

1