PMA P940015S012
- Device
- SYNVISC-ONE
- Applicant
- Sanofi Genzyme Corp.
- PMA number
- P940015
- Supplement
- S012
- Product code
- MOZ
- Decision date
- 2009-02-26
- Classification
- Acid, Hyaluronic, Intraarticular
- Generic name
- Acid, hyaluronic, intraarticular
- Approval order statement
- APPROVAL FOR THE SYNVISC-ONE. THE DEVICE IS INDICATED FOR THE TREATMENT OF PAIN IN OSTEOARTHRITIS OF THE KNEE IN PATIENTS WHO HAVE FILED TO RESPOND ADEQUATELY TO CONSERVATIVE NON-PHARMACOLOGIC THERAPY AND SIMPLE ANALGESICS, E.G., ACETAMINOPHEN.
- Summary
- <a href="http://www.accessdata.fda.gov/cdrh_docs/pdf/P940015S012B.pdf" target="_new">Summary of Safety and Effectiveness</a>
Current openFDA PMA Record#
- Device
- SYNVISC-ONE
- Applicant
- Sanofi Genzyme Corp.
- PMA number
- P940015
- Supplement
- S012
- Product code
- MOZ
- Generic name
- Acid, hyaluronic, intraarticular
- Decision date
- 2009-02-26
- Decision code
- APPR
- Date received
- 2007-06-19
- Supplement type
- Panel Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- APPROVAL FOR THE SYNVISC-ONE. THE DEVICE IS INDICATED FOR THE TREATMENT OF PAIN IN OSTEOARTHRITIS OF THE KNEE IN PATIENTS WHO HAVE FILED TO RESPOND ADEQUATELY TO CONSERVATIVE NON-PHARMACOLOGIC THERAPY AND SIMPLE ANALGESICS, E.G., ACETAMINOPHEN.