OPTIMIZER Smart System

FDA Premarket Approval P180036 S005

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.

Pre-market Approval Supplement Details

Approval for the removal of the contraindication “patients with permanent or long-standing persistent atrial fibrillation or flutter”.

DeviceOPTIMIZER Smart System
Generic NameImplantable Pulse Generator
ApplicantImpulse Dynamics (USA), Inc.
Date Received2020-02-26
Decision Date2020-09-02
PMAP180036
SupplementS005
Product CodeQFV 
Advisory CommitteeCardiovascular
Supplement TypeNormal 180 Day Track
Supplement ReasonLabeling Change - Indications/instructions/shelf Life/tradename
Expedited ReviewNo
Combination Product No
Applicant Address Impulse Dynamics (USA), Inc. 30 Ramland Road South, Suite 204 orangeburg, NY 10962

Supplemental Filings

Supplement NumberDateSupplement Type
P180036Original Filing
S005 2020-02-26 Normal 180 Day Track
S004 2020-01-09 Real-time Process
S003 2019-08-21 Normal 180 Day Track
S002 2019-06-21 Real-time Process
S001 2019-04-26 Real-time Process

NIH GUDID Devices

Device IDPMASupp
00810003380029 P180036 000
00810003380012 P180036 000
00810003380005 P180036 000

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