PMA P100044S022
- Device
- PROPEL AND PROPEL MINI SINUS IMPLANT
- Applicant
- Intersect Ent.
- PMA number
- P100044
- Supplement
- S022
- Product code
- OWO
- Decision date
- 2017-07-25
- Classification
- Drug-eluting Sinus Stent
- Generic name
- Drug-eluting sinus stent
- Approval order statement
- Approval for modification of the in-process drug coating weight specification from ± 5% to ± 7%.
Current openFDA PMA Record#
- Device
- PROPEL AND PROPEL MINI SINUS IMPLANT
- Applicant
- Intersect Ent.
- PMA number
- P100044
- Supplement
- S022
- Product code
- OWO
- Generic name
- Drug-eluting sinus stent
- Decision date
- 2017-07-25
- Decision code
- APPR
- Date received
- 2016-06-16
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for modification of the in-process drug coating weight specification from ± 5% to ± 7%.