GEL-ONE
FDA premarket approval P080020/S018 · decided 2015-11-25
Approval details
- PMA number
- P080020
- Supplement
- S018
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- GEL-ONE
- Generic name
- Acid, hyaluronic, intraarticular
- Applicant
- Seikagaku Corp.
- Date received
- 2015-08-31
- Decision date
- 2015-11-25
- Days to decision
- 86 days
- Decision code
- APPR
- Product code
- MOZ
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Tokyo
- Statement
- APPROVAL FOR A CHANGE TO THE MANUFACTURING AND STORING OF GEL-ONE® TO ALLOW FOR THE REFRIGERATION (5°C ± 3°C) OF IN-PROCESS PRODUCT (I.E. PRODUCT THAT HAS NOT YET BEEN PACKAGED AND LABELED) FOR A MAXIMUM OF 6 MONTHS FOLLOWING THE DATE OF TERMINAL STEAM STERILIZATION AND PRIOR TO INITIATION OF THE PRODUCT¿S PREVIOUSLY ESTABLISHED 12 MONTH SHELF LIFE WHEN STORED BELOW 25°C (WITHOUT FREEZING).
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| HADGEL, 4 GRAM/SYRINGE (K011544) | Seikagaku Corp. | 2001-08-15 |