Stellarex 0.035 OTW Drug-coated Angioplasty Balloon
FDA premarket approval P160049/S008 · decided 2020-02-11
Approval details
- PMA number
- P160049
- Supplement
- S008
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Stellarex 0.035 OTW Drug-coated Angioplasty Balloon
- Generic name
- Drug-Eluting Peripheral Transluminal Angioplasty Catheter
- Applicant
- The Spectranetics Corp.
- Date received
- 2020-01-15
- Decision date
- 2020-02-11
- Days to decision
- 27 days
- Decision code
- OK30
- Product code
- ONU
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Fremont, CA
- Statement
- Modified incoming inspection steps.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.