Stellarex 0.035 OTW Drug-coated Angioplasty Balloon
FDA premarket approval P160049/S001 · decided 2017-10-23
Approval details
- PMA number
- P160049
- Supplement
- S001
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Stellarex 0.035 OTW Drug-coated Angioplasty Balloon
- Generic name
- Drug-Eluting Peripheral Transluminal Angioplasty Catheter
- Applicant
- The Spectranetics Corp.
- Date received
- 2017-09-01
- Decision date
- 2017-10-23
- Days to decision
- 52 days
- Decision code
- APPR
- Product code
- ONU
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Fremont, CA
- Statement
- Approval for a new balloon length of 100 mm.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.