Resolute Integrity Coronary Stent Systems
FDA premarket approval P110013/S085 · decided 2017-12-20
Approval details
- PMA number
- P110013
- Supplement
- S085
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Resolute Integrity Coronary Stent Systems
- Generic name
- Coronary drug-eluting stent
- Applicant
- Medtronic Vascular
- Date received
- 2017-11-20
- Decision date
- 2017-12-20
- Days to decision
- 30 days
- Decision code
- OK30
- Product code
- NIQ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Santa Rosa, CA
- Statement
- Introduce software for monitoring the Controlled Environment Areas (CEAs) at the Empalme, Mexico manufacturing facility.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.