PMA P160049S011
- Device
- Stellarex 035 OTW Drug-Coated Angiopiasty Balloon (DCB)
- Applicant
- The Spectranetics Corp.
- PMA number
- P160049
- Supplement
- S011
- Product code
- ONU
- Decision date
- 2021-02-19
- Generic name
- Drug-Eluting Peripheral Transluminal Angioplasty Catheter
- Approval order statement
- Addition of sterilization chamber 4 in the Los Angeles, CA sterilization facility.
Current openFDA PMA Record#
- Device
- Stellarex 035 OTW Drug-Coated Angiopiasty Balloon (DCB)
- Applicant
- The Spectranetics Corp.
- PMA number
- P160049
- Supplement
- S011
- Product code
- ONU
- Generic name
- Drug-Eluting Peripheral Transluminal Angioplasty Catheter
- Decision date
- 2021-02-19
- Decision code
- OK30
- Date received
- 2021-01-21
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Addition of sterilization chamber 4 in the Los Angeles, CA sterilization facility.