PMA P160049S002
- Device
- Stellarex 0.035 OTW Drug-coated Angioplasty Balloon
- Applicant
- The Spectranetics Corp.
- PMA number
- P160049
- Supplement
- S002
- Product code
- ONU
- Decision date
- 2018-03-12
- Classification
- Drug-eluting Peripheral Transluminal Angioplasty Catheter
- Generic name
- Drug-Eluting Peripheral Transluminal Angioplasty Catheter
- Approval order statement
- Approval for process changes related to the coating process.
Current openFDA PMA Record#
- Device
- Stellarex 0.035 OTW Drug-coated Angioplasty Balloon
- Applicant
- The Spectranetics Corp.
- PMA number
- P160049
- Supplement
- S002
- Product code
- ONU
- Generic name
- Drug-Eluting Peripheral Transluminal Angioplasty Catheter
- Decision date
- 2018-03-12
- Decision code
- APPR
- Date received
- 2018-01-22
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for process changes related to the coating process.