Integrity Coronary Stent System (hereafter called Integrity)
FDA premarket approval P030009/S102 · decided 2021-05-11
Approval details
- PMA number
- P030009
- Supplement
- S102
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Integrity Coronary Stent System (hereafter called Integrity)
- Generic name
- STENT, CORONARY
- Applicant
- Medtronic, Ireland
- Date received
- 2021-04-12
- Decision date
- 2021-05-11
- Days to decision
- 29 days
- Decision code
- OK30
- Product code
- MAF
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Galway
- Statement
- Transfer of component extrusion manufacturing operations from the Santa Rosa to the Danvers site.
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