PMA P160049S019
- Device
- Stellarex 035 Drug Coated Balloon Percutaneous Transluminal Angioplasty Catheter
- Applicant
- The Spectranetics Corp.
- PMA number
- P160049
- Supplement
- S019
- Product code
- ONU
- Decision date
- 2022-07-15
- Generic name
- Drug-Eluting Peripheral Transluminal Angioplasty Catheter
- Approval order statement
- Change in supplier of a packaging material.
Current openFDA PMA Record#
- Device
- Stellarex 035 Drug Coated Balloon Percutaneous Transluminal Angioplasty Catheter
- Applicant
- The Spectranetics Corp.
- PMA number
- P160049
- Supplement
- S019
- Product code
- ONU
- Generic name
- Drug-Eluting Peripheral Transluminal Angioplasty Catheter
- Decision date
- 2022-07-15
- Decision code
- OK30
- Date received
- 2022-06-14
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Change in supplier of a packaging material.