SCULPTRA 2 Vials
SCULPTRA 2 Vials is a Class III device made by Saima Global Farma S.L., approved under FDA PMA P030050 on 3 Aug 2004 and listed in FDA GUDID since 19 Feb 2026 (UDI-DI 08437027710117), active as of 23 Oct 2026.
Active
PMA
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number08437027710117 | Date19 Feb 2026 | StatusListed |
| United States | FDA PMAAPPR | NumberP030050 | Date3 Aug 2004 | StatusActive |
Official records
- AccessGUDID record 08437027710117
- FDA PMA database P030050
Across registries
- FDA PMA P030050 decided 3 Aug 2004 Active
- FDA GUDID UDI-DI 08437027710117 listed 19 Feb 2026 Listed
Timeline
- Approved FDA PMA P030050
- Listed FDA GUDID 08437027710117
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA PMA Active
Specification
- Trade name
- Sculptra
- Generic name
- Dermal tissue reconstructive material, synthetic mineral
- Model / reference
- 2 Vials
- Primary DI / UDI-DI
- 08437027710117
- PMA number
- FDA product code
- LMH
- GMDN term
- Dermal tissue reconstructive material, synthetic mineral
- Device class
- Class III
- GUDID distribution status
- In Commercial Distribution
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