PMA P100044S011
- Device
- PROPEL SINUS IMPLANT, PROPEL MINI SINUS IMPLANT
- Applicant
- Intersect Ent.
- PMA number
- P100044
- Supplement
- S011
- Product code
- OWO
- Decision date
- 2013-09-18
- Classification
- Drug-eluting Sinus Stent
- Generic name
- Drug-eluting sinus stent
- Approval order statement
- ADD A NEW LABELING SUPPLIER FOR THE DEVICE.
Current openFDA PMA Record#
- Device
- PROPEL SINUS IMPLANT, PROPEL MINI SINUS IMPLANT
- Applicant
- Intersect Ent.
- PMA number
- P100044
- Supplement
- S011
- Product code
- OWO
- Generic name
- Drug-eluting sinus stent
- Decision date
- 2013-09-18
- Decision code
- OK30
- Date received
- 2013-08-21
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- ADD A NEW LABELING SUPPLIER FOR THE DEVICE.