Gel-One
FDA premarket approval P080020/S042 · decided 2021-04-15
Approval details
- PMA number
- P080020
- Supplement
- S042
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Gel-One
- Generic name
- Acid, hyaluronic, intraarticular
- Applicant
- Seikagaku Corp.
- Date received
- 2021-03-18
- Decision date
- 2021-04-15
- Days to decision
- 28 days
- Decision code
- OK30
- Product code
- MOZ
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Tokyo
- Statement
- Sharing the facility and equipment used to manufacture Gel-One for the purpose of manufacturing an investigational drug substance.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| HADGEL, 4 GRAM/SYRINGE (K011544) | Seikagaku Corp. | 2001-08-15 |