DDD PULSE GENERATOR 674

FDA Premarket Approval P840014

Pre-market Approval Supplement Details

• Device: DDD PULSE GENERATOR 674
• Generic Name: Implantable Pulse Generator, Pacemaker (non-crt)
• Applicant: PACESETTER SYSTEMS
• Date Received: 1984-03-21
• Decision Date: 1986-07-31
• Notice Date: 1986-09-08
• PMA: P840014
• Supplement: S
• Product Code: LWP
• Docket Number: 86M-0343
• Advisory Committee: Cardiovascular
• Expedited Review: No
• Combination Product: No
• Applicant Address: PACESETTER SYSTEMS 12884 Bradley Ave. sylmar, CA 91342

Supplemental Filings

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Supplement Number	Date	Supplement Type
P840014		Original Filing