INTEGRITY CORONARY STENT SYSTEM
FDA premarket approval P030009/S079 · decided 2014-07-31
Approval details
- PMA number
- P030009
- Supplement
- S079
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- INTEGRITY CORONARY STENT SYSTEM
- Generic name
- STENT, CORONARY
- Applicant
- Medtronic, Ireland
- Date received
- 2014-07-02
- Decision date
- 2014-07-31
- Days to decision
- 29 days
- Decision code
- OK30
- Product code
- MAF
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Galway
- Statement
- CHANGES TO THE SUB-ASSEMBLY MANUFACTURING PROCESS.
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