DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM (OAS)
FDA premarket approval P130005/S004 · decided 2015-05-14
Approval details
- PMA number
- P130005
- Supplement
- S004
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM (OAS)
- Generic name
- CATHETER, CORONARY, ATHERECTOMY
- Applicant
- Cardiovascular Systems, Inc.
- Date received
- 2014-12-11
- Decision date
- 2015-05-14
- Days to decision
- 154 days
- Decision code
- APPR
- Product code
- MCX
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- APPROVAL FOR A CHANGE TO THE SEALING PROCESS FOR THE NOSECONE-TO-GLUE PLUG AND GLUE PLUG-TO-SALINE SHEATH BONDS TO USE LIGHT WITHIN A NARROWER ULTRAVIOLET (UV) WAVELENGTH FOR CURING THE SEALING ADHESIVE.
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