Synvisc-One® 002401
Synvisc-One® 002401 is a Class III device made by Genzyme Corp., approved under FDA PMA P940015 on 8 Aug 1997 and listed in FDA GUDID since 24 Sep 2014 (UDI-DI 20358468019114), active as of 23 Oct 2026. One FDA recall is linked to it.
Active
PMA
Valid until
No expiry
FDA recalls
None ongoingDocuments
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number20358468019114 | Date24 Sep 2014 | StatusListed |
| United States | FDA PMAAPPR | NumberP940015 | Date8 Aug 1997 | StatusActive |
Official records
- AccessGUDID record 20358468019114
- FDA PMA database P940015
Across registries
- FDA PMA P940015 decided 8 Aug 1997 Active
- FDA GUDID UDI-DI 20358468019114 listed 24 Sep 2014 Listed
Recalls
-
- Terminated Z-0607-2018
Contamination with Methylbacterium thiocyanatum
Timeline
- Approved FDA PMA P940015
- Listed FDA GUDID 20358468019114
- Recall initiated FDA recalls Z-0607-2018
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA PMA Active
Specification
- Trade name
- Synvisc-One®
- Generic name
- Synovial fluid supplementation medium
- Model / reference
- 002401
- Primary DI / UDI-DI
- 20358468019114
- PMA number
- FDA product code
- MOZ
- GMDN term
- Synovial fluid supplementation medium
- Device class
- Class III
- GUDID distribution status
- In Commercial Distribution
- Size
- Total Volume — 6 Milliliter
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