PMA P140002S012
- Device
- Misago RX Self-expanding Peripheral Stent
- Applicant
- Terumo Medical Corporation
- PMA number
- P140002
- Supplement
- S012
- Product code
- NIP
- Decision date
- 2018-04-30
- Classification
- Stent, Superficial Femoral Artery
- Generic name
- STENT, SUPERFICIAL FEMORAL ARTERY
- Approval order statement
- Relocation of the sterility testing room within the same facility and an update to the clean room ISO classification.
Current openFDA PMA Record#
- Device
- Misago RX Self-expanding Peripheral Stent
- Applicant
- Terumo Medical Corporation
- PMA number
- P140002
- Supplement
- S012
- Product code
- NIP
- Generic name
- STENT, SUPERFICIAL FEMORAL ARTERY
- Decision date
- 2018-04-30
- Decision code
- OK30
- Date received
- 2018-04-04
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Relocation of the sterility testing room within the same facility and an update to the clean room ISO classification.