PMA P960057S003
- Device
- ADCON -L ADHESION CONTROL IN A BARRIER GEL
- Applicant
- Wrightmedicaltechnologyinc
- PMA number
- P960057
- Supplement
- S003
- Product code
- MLQ
- Decision date
- 1999-01-14
- Classification
- Inhibitor, Peridural Fibrosis (adhesion Barrier)
- Generic name
- Inhibitor, peridural fibrosis (adhesion barrier)
- Approval order statement
- The 30-Day Notice requested a change in the water temperature, mixing time and mixing speed used in the manufacturing process for the Adcon(R)-L Adhesion Control Barrier Gel. The proposed modifications are designed to increase the efficiency of the gel manufacturing process.
Current openFDA PMA Record#
- Device
- ADCON -L ADHESION CONTROL IN A BARRIER GEL
- Applicant
- Wrightmedicaltechnologyinc
- PMA number
- P960057
- Supplement
- S003
- Product code
- MLQ
- Generic name
- Inhibitor, peridural fibrosis (adhesion barrier)
- Decision date
- 1999-01-14
- Decision code
- OK30
- Date received
- 1998-12-21
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- The 30-Day Notice requested a change in the water temperature, mixing time and mixing speed used in the manufacturing process for the Adcon(R)-L Adhesion Control Barrier Gel. The proposed modifications are designed to increase the efficiency of the gel manufacturing process.