PMA P160049S007
- Device
- Stellarex 0.035 OTW Drug-coated Angioplasty Ballon
- Applicant
- The Spectranetics Corp.
- PMA number
- P160049
- Supplement
- S007
- Product code
- ONU
- Decision date
- 2019-09-13
- Classification
- Drug-eluting Peripheral Transluminal Angioplasty Catheter
- Generic name
- Drug-Eluting Peripheral Transluminal Angioplasty Catheter
- Approval order statement
- Approval for updates to the device labeling.
Current openFDA PMA Record#
- Device
- Stellarex 0.035 OTW Drug-coated Angioplasty Ballon
- Applicant
- The Spectranetics Corp.
- PMA number
- P160049
- Supplement
- S007
- Product code
- ONU
- Generic name
- Drug-Eluting Peripheral Transluminal Angioplasty Catheter
- Decision date
- 2019-09-13
- Decision code
- APPR
- Date received
- 2019-09-03
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for updates to the device labeling.