PMA P100044S002
- Device
- PROPEL SINUS IMPLANT
- Applicant
- Intersect Ent.
- PMA number
- P100044
- Supplement
- S002
- Product code
- OWO
- Decision date
- 2012-08-10
- Classification
- Drug-eluting Sinus Stent
- Generic name
- Drug-eluting sinus stent
- Approval order statement
- MODIFICATION TO A QUALITY CONTROL TEST USED ON AN INCOMING COMPONENT.
Current openFDA PMA Record#
- Device
- PROPEL SINUS IMPLANT
- Applicant
- Intersect Ent.
- PMA number
- P100044
- Supplement
- S002
- Product code
- OWO
- Generic name
- Drug-eluting sinus stent
- Decision date
- 2012-08-10
- Decision code
- OK30
- Date received
- 2012-07-31
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- MODIFICATION TO A QUALITY CONTROL TEST USED ON AN INCOMING COMPONENT.