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: CYBERLITH IV UNIPOLAR PULSE GENERATOR
• Generic Name: Implantable pulse generator, pacemaker (non-CRT)
• Applicant: Boston Scientific; 4100 Hamline Ave. N; St Paul, MN 55112
• PMA Number: P800019
• Supplement Number: S010
• Date Received: 09/15/1989
• Decision Date: 02/16/1990
• Withdrawal Date: 07/19/2012
• Product Code: LWP
• Advisory Committee: Cardiovascular
• Supplement Type: Normal 180 Day Track
• Supplement Reason: Other
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No