PMA P040047S011
- Device
- COAPTITE INJECTABLE IMPLANT
- Applicant
- Merz North America, Inc.
- PMA number
- P040047
- Supplement
- S011
- Product code
- LNM
- Decision date
- 2009-03-11
- Classification
- Agent, Bulking, Injectable For Gastro-urology Use
- Generic name
- AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE
- Approval order statement
- APPROVAL FOR A SECOND CONVECTION OVEN.
Current openFDA PMA Record#
- Device
- COAPTITE INJECTABLE IMPLANT
- Applicant
- Merz North America, Inc.
- PMA number
- P040047
- Supplement
- S011
- Product code
- LNM
- Generic name
- AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE
- Decision date
- 2009-03-11
- Decision code
- APPR
- Date received
- 2008-11-06
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL FOR A SECOND CONVECTION OVEN.