PMA P040047S062
- Device
- COAPTITE Injectable Implant
- Applicant
- Merz North America, Inc.
- PMA number
- P040047
- Supplement
- S062
- Product code
- LNM
- Decision date
- 2020-10-14
- Generic name
- AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE
- Approval order statement
- Qualify the Keyence Image Dimension Measurement System for inspection of up to thirty-six (36) syringe plunger end caps simultaneously.
Current openFDA PMA Record#
- Device
- COAPTITE Injectable Implant
- Applicant
- Merz North America, Inc.
- PMA number
- P040047
- Supplement
- S062
- Product code
- LNM
- Generic name
- AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE
- Decision date
- 2020-10-14
- Decision code
- OK30
- Date received
- 2020-09-18
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Qualify the Keyence Image Dimension Measurement System for inspection of up to thirty-six (36) syringe plunger end caps simultaneously.