Stellarex 0.035 OTW Drug-coated Angioplasty Balloon
FDA premarket approval P160049/S010 · decided 2021-10-28
Approval details
- PMA number
- P160049
- Supplement
- S010
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location 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
- 2020-12-16
- Decision date
- 2021-10-28
- Days to decision
- 316 days
- Decision code
- APPR
- Product code
- ONU
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Fremont, CA
- Statement
- Approval for a manufacturing site located at Philips Image Guided Therapy Devices, 5905 Nathan Lane North, Plymouth, MN for a site change of the analytical laboratory for stability testing of Stellarex 0.035 Drug Coated Angioplasty Balloon.
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