PMA P160049S003
- Device
- STELLAREX 0.035 OTW DRUG-COATED ANGIOPLASTY BALLOON
- Applicant
- The Spectranetics Corp.
- PMA number
- P160049
- Supplement
- S003
- Product code
- ONU
- Decision date
- 2018-11-16
- Classification
- Drug-eluting Peripheral Transluminal Angioplasty Catheter
- Generic name
- Drug-Eluting Peripheral Transluminal Angioplasty Catheter
- Approval order statement
- Approval for a labeling update with 2 year data.
Current openFDA PMA Record#
- Device
- STELLAREX 0.035 OTW DRUG-COATED ANGIOPLASTY BALLOON
- Applicant
- The Spectranetics Corp.
- PMA number
- P160049
- Supplement
- S003
- Product code
- ONU
- Generic name
- Drug-Eluting Peripheral Transluminal Angioplasty Catheter
- Decision date
- 2018-11-16
- Decision code
- APPR
- Date received
- 2018-10-01
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - PAS
- Approval order statement
- Approval for a labeling update with 2 year data.