PMA P100044S004
- Device
- PROPEL SINUS IMPLANT
- Applicant
- Intersect Ent.
- PMA number
- P100044
- Supplement
- S004
- Product code
- OWO
- Decision date
- 2013-05-22
- Classification
- Drug-eluting Sinus Stent
- Generic name
- Drug-eluting sinus stent
- Approval order statement
- APPROVAL FOR A REVISED DRUG RELEASE SPECIFICATION RANGE FOR THE DRUG RELEASE TEST PER A CONDITION OF APPROVAL.
Current openFDA PMA Record#
- Device
- PROPEL SINUS IMPLANT
- Applicant
- Intersect Ent.
- PMA number
- P100044
- Supplement
- S004
- Product code
- OWO
- Generic name
- Drug-eluting sinus stent
- Decision date
- 2013-05-22
- Decision code
- APPR
- Date received
- 2012-12-14
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR A REVISED DRUG RELEASE SPECIFICATION RANGE FOR THE DRUG RELEASE TEST PER A CONDITION OF APPROVAL.