PMA P110003
- Device
- LEGOO
- Applicant
- Genzyme Corp.
- PMA number
- P110003
- Supplement
- S004
- Product code
- OBC
- Decision date
- 2014-03-26
- Generic name
- Occluder, internal vessel, temporary
- Approval order statement
- IMPLEMENTATION OF A MODIFIED LEGOO FILLING AND INSPECTION PROCESS FOR THE 1.0 ML AND 2.5 ML LEGOO SYRINGES.
Current openFDA PMA Record#
- Device
- LEGOO
- Applicant
- Genzyme Corp.
- PMA number
- P110003
- Supplement
- S004
- Product code
- OBC
- Generic name
- Occluder, internal vessel, temporary
- Decision date
- 2014-03-26
- Decision code
- OK30
- Date received
- 2014-02-27
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- IMPLEMENTATION OF A MODIFIED LEGOO FILLING AND INSPECTION PROCESS FOR THE 1.0 ML AND 2.5 ML LEGOO SYRINGES.