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: FNLN2 SXP BP, FNLN2 SXP PF BP, FNLN2 SX PF BP, FNLN2 SXP J BP,
• 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: P960004
• Supplement Number: S096
• Date Received: 09/23/2021
• Decision Date: 09/24/2021
• 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  
Change the adhesive and liner used on the tray label stock for pulse generators and Leads.