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: Sweet Tip (R) Rx Steroid Eluting Lead
• Generic Name: Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
• Applicant: Boston Scientific; 4100 Hamline Ave. N; St Paul, MN 55112
• PMA Number: P960006
• Supplement Number: S054
• Date Received: 09/30/2021
• Decision Date: 10/04/2021
• Product Code: NVN
• Advisory Committee: Cardiovascular
• Supplement Type: 30-Day Notice
• Supplement Reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
• Expedited Review Granted?: No
• Combination Product: Yes
• Predetermined Change Control Plan Authorized: No

Approval Order Statement  
Alternate stylet tip forming and inspection manufacturing processes that are performed at the supplier.