DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM (OAS)
FDA premarket approval P130005/S005 · decided 2015-07-07
Approval details
- PMA number
- P130005
- Supplement
- S005
- 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
- 2014-12-18
- Decision date
- 2015-07-07
- Days to decision
- 201 days
- Decision code
- APPR
- Product code
- MCX
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- APPROVAL OF CHANGES TO THE STERILIZATION PROCESS, INCLUDING AN ADDITIONAL STERILIZATION CHAMBER, ALTERNATIVE CONFIGURATIONS FOR PROCESS CHALLENGE DEVICES, REDUCTION IN AERATION TIME, AND ADDITIONAL POST-NITROGEN WASHES AND EVACUATIONS.
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