RESOLUTE INTEGRITY ZOTAROLIMUS ELUTING CORONARY STENT SYSTEM
FDA premarket approval P110013/S017 · decided 2013-07-02
Approval details
- PMA number
- P110013
- Supplement
- S017
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol - OSB
- Trade name
- RESOLUTE INTEGRITY ZOTAROLIMUS ELUTING CORONARY STENT SYSTEM
- Generic name
- Coronary drug-eluting stent
- Applicant
- Medtronic Vascular
- Date received
- 2013-04-05
- Decision date
- 2013-07-02
- Days to decision
- 88 days
- Decision code
- APPR
- Product code
- NIQ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Santa Rosa, CA
- Statement
- APPROVAL FOR AN UPDATED ANNUAL STABILITY PROTOCOL TO BRACKET THE ADDITIONAL 34 MM AND 38 MM LENGTH STENT SIZES.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.