PMA P100014S014
- Device
- SOLESTA
- Applicant
- Palette Life Sciences
- PMA number
- P100014
- Supplement
- S014
- Product code
- LNM
- Decision date
- 2014-08-28
- Classification
- Agent, Bulking, Injectable For Gastro-urology Use
- Generic name
- AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE
- Approval order statement
- APPROVAL FOR A CHANGE OF THE MANUFACTURER OF NEEDLES THAT ARE SUPPLIED WITH THE SOLESTA DEVICE.
Current openFDA PMA Record#
- Device
- SOLESTA
- Applicant
- Palette Life Sciences
- PMA number
- P100014
- Supplement
- S014
- Product code
- LNM
- Generic name
- AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE
- Decision date
- 2014-08-28
- Decision code
- APPR
- Date received
- 2014-06-12
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL FOR A CHANGE OF THE MANUFACTURER OF NEEDLES THAT ARE SUPPLIED WITH THE SOLESTA DEVICE.