RESOLUTE INTEGRITY RX ZOTAROLIMUS-ELUTING CORNARY STENT SYSTEM; RESOLUTE INTEGRITY OTW ZOTAROLINUS ELUTING STENT SYSTEM
FDA premarket approval P110013/S031 · decided 2013-12-19
Approval details
- PMA number
- P110013
- Supplement
- S031
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- RESOLUTE INTEGRITY RX ZOTAROLIMUS-ELUTING CORNARY STENT SYSTEM; RESOLUTE INTEGRITY OTW ZOTAROLINUS ELUTING STENT SYSTEM
- Generic name
- Coronary drug-eluting stent
- Applicant
- Medtronic Vascular
- Date received
- 2013-11-22
- Decision date
- 2013-12-19
- Days to decision
- 27 days
- Decision code
- OK30
- Product code
- NIQ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Santa Rosa, CA
- Statement
- CHANGES RELATED TO THE SOFTWARE USED IN THE MEASUREMENT PROCESS OF THE WAVEFORMS AT THE ¿WAVE FORMING¿ WORK STEP AND THE STENTS AT THE ¿ELECTRO-POLISH¿ WORK STEP.
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