DISCRETE TECHNOLOGY(TM)OVER-THE-WIRE/RAPID EXCHANGE CORONARY STENT SYSTEM
FDA premarket approval P970035/S024 · decided 2001-03-19
Approval details
- PMA number
- P970035
- Supplement
- S024
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- DISCRETE TECHNOLOGY(TM)OVER-THE-WIRE/RAPID EXCHANGE CORONARY STENT SYSTEM
- Generic name
- STENT, CORONARY
- Applicant
- Medtronic, Ireland
- Date received
- 2001-02-20
- Decision date
- 2001-03-19
- Days to decision
- 27 days
- Decision code
- OK30
- Product code
- MAF
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Galway
- Statement
- CHANGE FROM AN OIL-BASE COOLANT USED DURING RING MACHING PROCESS TO A WATER-BASE COOLANT, AND PROPOSES TO CHANGE THE ALCOHOL AND HFE SOLVENT CLEANER USED DURING RING MACHINING TO A WATER-BASE CLEANING SOLUTION FOR BOTH THE S670 AND S660 PRODUCTS.
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