PMA P110003S003
- Device
- LEGOO
- Applicant
- Genzyme Corp.
- PMA number
- P110003
- Supplement
- S003
- Product code
- OBC
- Decision date
- 2012-11-13
- Generic name
- Occluder, internal vessel, temporary
- Approval order statement
- CHANGES TO THE PACKAGING CONFIGURATIONS BY REDUCING THE NUMBER OF TYVEK POUCHED CANNULAE PER SALES CARTON.
Current openFDA PMA Record#
- Device
- LEGOO
- Applicant
- Genzyme Corp.
- PMA number
- P110003
- Supplement
- S003
- Product code
- OBC
- Generic name
- Occluder, internal vessel, temporary
- Decision date
- 2012-11-13
- Decision code
- OK30
- Date received
- 2012-10-19
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- CHANGES TO THE PACKAGING CONFIGURATIONS BY REDUCING THE NUMBER OF TYVEK POUCHED CANNULAE PER SALES CARTON.