PMA P100014S015
- Device
- SOLESTA INJECTABLE GEL
- Applicant
- Palette Life Sciences
- PMA number
- P100014
- Supplement
- S015
- Product code
- LNM
- Decision date
- 2014-08-07
- Classification
- Agent, Bulking, Injectable For Gastro-urology Use
- Generic name
- AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE
- Approval order statement
- INTRODUCTION OF AN ALTERNATE SUPPLIER FOR TWO PROCESS CHEMICALS USED IN THE BULK MANUFACTURING PROCESS OF SOLESTA.
Current openFDA PMA Record#
- Device
- SOLESTA INJECTABLE GEL
- Applicant
- Palette Life Sciences
- PMA number
- P100014
- Supplement
- S015
- Product code
- LNM
- Generic name
- AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE
- Decision date
- 2014-08-07
- Decision code
- OK30
- Date received
- 2014-07-07
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- INTRODUCTION OF AN ALTERNATE SUPPLIER FOR TWO PROCESS CHEMICALS USED IN THE BULK MANUFACTURING PROCESS OF SOLESTA.