PMA P040047S052
- Device
- Coaptite
- Applicant
- Merz North America, Inc.
- PMA number
- P040047
- Supplement
- S052
- Product code
- LNM
- Decision date
- 2019-06-26
- Classification
- Agent, Bulking, Injectable For Gastro-urology Use
- Generic name
- AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE
- Approval order statement
- Approval for a Post-Approval Study Labeling update.
Current openFDA PMA Record#
- Device
- Coaptite
- Applicant
- Merz North America, Inc.
- PMA number
- P040047
- Supplement
- S052
- Product code
- LNM
- Generic name
- AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE
- Decision date
- 2019-06-26
- Decision code
- APPR
- Date received
- 2019-01-07
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for a Post-Approval Study Labeling update.