PMA P980053S014
- Device
- DURASPHERE INECTABLE BULKING AGENT
- Applicant
- Carbon Medical Technologies, Inc.
- PMA number
- P980053
- Supplement
- S014
- Product code
- LNM
- Decision date
- 2013-03-21
- Classification
- Agent, Bulking, Injectable For Gastro-urology Use
- Generic name
- AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE
- Approval order statement
- MODIFICATION TO THE FOIL POUCH SEALER, AND THE ADDITION OF TWO ALTERNATE SEALERS, AND TWO NEW LABEL PRINTING SYSTEMS.
Current openFDA PMA Record#
- Device
- DURASPHERE INECTABLE BULKING AGENT
- Applicant
- Carbon Medical Technologies, Inc.
- PMA number
- P980053
- Supplement
- S014
- Product code
- LNM
- Generic name
- AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE
- Decision date
- 2013-03-21
- Decision code
- OK30
- Date received
- 2013-02-19
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- MODIFICATION TO THE FOIL POUCH SEALER, AND THE ADDITION OF TWO ALTERNATE SEALERS, AND TWO NEW LABEL PRINTING SYSTEMS.