Premarket Approval (PMA)

Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.

• Device: S670 W/DISCRETE TECHNOLOGY OTW/RAPID EXCHANGE CORONARY STENT SYSTEM
• Generic Name: STENT, CORONARY
• Applicant: Medtronic, Ireland; Parkmore Business Park W.; Galway
• PMA Number: P970035
• Supplement Number: S020
• Date Received: 05/04/2000
• Decision Date: 05/16/2000
• Withdrawal Date: 10/18/2010
• Product Code: MAF
• Advisory Committee: Cardiovascular
• Supplement Type: 30-Day Notice
• Supplement Reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No

Approval Order Statement  
Changes to modify the electropolish process.