Stellarex 0.035 OTW Drug-coated Angioplasty Balloon
FDA premarket approval P160049/S006 · decided 2019-06-12
Approval details
- PMA number
- P160049
- Supplement
- S006
- 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
- 2019-05-13
- Decision date
- 2019-06-12
- Days to decision
- 30 days
- Decision code
- OK30
- Product code
- ONU
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Fremont, CA
- Statement
- New labeling software for printing product labels.
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