S7 WITH DIS OVER-THE WIRE CORONARY STENT SYSTEM AND S7 WITH DISCRETE TECHN RAPID EXCHANGE CORONARY STENT SYSTEM
FDA premarket approval P970035/S027 · decided 2001-05-29
Approval details
- PMA number
- P970035
- Supplement
- S027
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- S7 WITH DIS OVER-THE WIRE CORONARY STENT SYSTEM AND S7 WITH DISCRETE TECHN RAPID EXCHANGE CORONARY STENT SYSTEM
- Generic name
- STENT, CORONARY
- Applicant
- Medtronic, Ireland
- Date received
- 2001-05-11
- Decision date
- 2001-05-29
- Days to decision
- 18 days
- Decision code
- OK30
- Product code
- MAF
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Galway
- Statement
- CHANGE TO THE MANUFACTURING PROCESS TO INCREASE THE LENGTH AND INNER DIAMETER OF THE THIRD AND FOURTH TFE BAKING SHEATHS IN SIZE TO FACILITATE THEIR APPLICATION DURING THE STENT/BALLOON BAKING PROCESS.
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