PMA P100044S012
- Device
- INTERSECT ENT PROPEL MINI SINUS IMPLANT
- Applicant
- Intersect Ent.
- PMA number
- P100044
- Supplement
- S012
- Product code
- OWO
- Decision date
- 2014-01-31
- Classification
- Drug-eluting Sinus Stent
- Generic name
- Drug-eluting sinus stent
- Approval order statement
- APPROVAL TO REVISE THE RELEASE RATE SPECIFICATION.
Current openFDA PMA Record#
- Device
- INTERSECT ENT PROPEL MINI SINUS IMPLANT
- Applicant
- Intersect Ent.
- PMA number
- P100044
- Supplement
- S012
- Product code
- OWO
- Generic name
- Drug-eluting sinus stent
- Decision date
- 2014-01-31
- Decision code
- APPR
- Date received
- 2013-09-30
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL TO REVISE THE RELEASE RATE SPECIFICATION.