GEL-ONE
FDA premarket approval P080020/S014 · decided 2015-08-03
Approval details
- PMA number
- P080020
- Supplement
- S014
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- GEL-ONE
- Generic name
- Acid, hyaluronic, intraarticular
- Applicant
- Seikagaku Corp.
- Date received
- 2015-05-05
- Decision date
- 2015-08-03
- Days to decision
- 90 days
- Decision code
- APPR
- Product code
- MOZ
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Tokyo
- Statement
- APPROVAL FOR REVISIONS TO THE PACKAGE INSERT AND THE PATIENT INFORMATION FOR GEL-ONE® AS FOLLOWS: 1) REVISION OF THE STATEMENT, THE SAFETY AND EFFECTIVENESS OF A REPEAT TREATMENT CYCLE OF GEL-ONE® HAVE NOT BEEN ESTABLISHED. TO THE STATEMENT, THE EFFECTIVENESS OF REPEAT TREATMENT CYCLES OF GEL-ONE® HAS NOT BEEN ESTABLISHED; AND 2) CITATION OF CLINICAL STUDY DATA FOR RETREATMENT WITH GEL-ONE® IN SUPPORT OF THE REVISION OF THIS STATEMENT AS DESCRIBED ABOVE.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.
510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| HADGEL, 4 GRAM/SYRINGE (K011544) | Seikagaku Corp. | 2001-08-15 |