PMA P100014S011
- Device
- SOLESTA
- Applicant
- Palette Life Sciences
- PMA number
- P100014
- Supplement
- S011
- Product code
- LNM
- Decision date
- 2014-02-26
- Classification
- Agent, Bulking, Injectable For Gastro-urology Use
- Generic name
- AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE
- Approval order statement
- APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
Current openFDA PMA Record#
- Device
- SOLESTA
- Applicant
- Palette Life Sciences
- PMA number
- P100014
- Supplement
- S011
- Product code
- LNM
- Generic name
- AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE
- Decision date
- 2014-02-26
- Decision code
- APPR
- Date received
- 2013-11-04
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol - OSB
- Approval order statement
- APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.