PMA P980053S001
- Device
- DURASPHERE INJECTABLE BULKING AGENT
- Applicant
- Carbon Medical Technologies, Inc.
- PMA number
- P980053
- Supplement
- S001
- Product code
- LNM
- Decision date
- 2000-11-01
- Classification
- Agent, Bulking, Injectable For Gastro-urology Use
- Generic name
- AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE
- Approval order statement
- ADDITION OF AN ALTERNATE SUBCONTRACTOR TO HEAT-SEAL THE TRAY LID PACKAGE FOR THE DURASPHERE INJECTABLE BULKING AGENT(R) AND AN ALTERNATE SUPPLIER FOR TYVEC 1078B LID FOR USE BY THE ALTERNATE SUBCONTRACTOR.
Current openFDA PMA Record#
- Device
- DURASPHERE INJECTABLE BULKING AGENT
- Applicant
- Carbon Medical Technologies, Inc.
- PMA number
- P980053
- Supplement
- S001
- Product code
- LNM
- Generic name
- AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE
- Decision date
- 2000-11-01
- Decision code
- OK30
- Date received
- 2000-10-06
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- ADDITION OF AN ALTERNATE SUBCONTRACTOR TO HEAT-SEAL THE TRAY LID PACKAGE FOR THE DURASPHERE INJECTABLE BULKING AGENT(R) AND AN ALTERNATE SUPPLIER FOR TYVEC 1078B LID FOR USE BY THE ALTERNATE SUBCONTRACTOR.