PMA P100044S008
- Device
- INTERSECTENT PROPEL MINI SINUS IMPLANT
- Applicant
- Intersect Ent.
- PMA number
- P100044
- Supplement
- S008
- Product code
- OWO
- Decision date
- 2013-07-17
- Classification
- Drug-eluting Sinus Stent
- Generic name
- Drug-eluting sinus stent
- Approval order statement
- AGREED TO THE RECOMMENDATION TO REVISE THE STABILITY PROTOCOL TO REFLECT THE DRUG RELEASE ACCEPTANCE CRITERIA OF ± 12% OF THE TARGET VALUE USED FOR PRODUCT RELEASE.
Current openFDA PMA Record#
- Device
- INTERSECTENT PROPEL MINI SINUS IMPLANT
- Applicant
- Intersect Ent.
- PMA number
- P100044
- Supplement
- S008
- Product code
- OWO
- Generic name
- Drug-eluting sinus stent
- Decision date
- 2013-07-17
- Decision code
- APPR
- Date received
- 2013-03-04
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Other
- Approval order statement
- AGREED TO THE RECOMMENDATION TO REVISE THE STABILITY PROTOCOL TO REFLECT THE DRUG RELEASE ACCEPTANCE CRITERIA OF ± 12% OF THE TARGET VALUE USED FOR PRODUCT RELEASE.