RESOLUTE INTEGRITY RX ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM
FDA premarket approval P110013/S026 · decided 2013-10-24
Approval details
- PMA number
- P110013
- Supplement
- S026
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- RESOLUTE INTEGRITY RX ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM
- Generic name
- Coronary drug-eluting stent
- Applicant
- Medtronic Vascular
- Date received
- 2013-09-26
- Decision date
- 2013-10-24
- Days to decision
- 28 days
- Decision code
- OK30
- Product code
- NIQ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Santa Rosa, CA
- Statement
- CHANGES TO THE VISION ASSIST PRECISION WELDER INCLUDING THE ADDITION OF A NEW MOTOR, REPLACEMENT OF THE CHUCK/COLLET FIXTURE, REMOVAL OF THE SCAN BY THE OVERHEAD CAMERA, AND UPDATED SOFTWARE TO ENSURE APPROPRIATE SET-UP IS COMPLETED.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.