PMA P110003S001
- Device
- LEGOO ENDOVASCULAR OCCLUDER
- Applicant
- Genzyme Corp.
- PMA number
- P110003
- Supplement
- S001
- Product code
- OBC
- Decision date
- 2012-03-01
- Generic name
- Occluder, internal vessel, temporary
- Approval order statement
- APPROVAL FOR A CHANGE TO A STERILIZATION PROCESS PARAMETER.
Current openFDA PMA Record#
- Device
- LEGOO ENDOVASCULAR OCCLUDER
- Applicant
- Genzyme Corp.
- PMA number
- P110003
- Supplement
- S001
- Product code
- OBC
- Generic name
- Occluder, internal vessel, temporary
- Decision date
- 2012-03-01
- Decision code
- APPR
- Date received
- 2011-11-15
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL FOR A CHANGE TO A STERILIZATION PROCESS PARAMETER.