Optimizer Smart System and Optimizer Smart Mini System

FDA Premarket Approval P180036 S008

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 removing the indications for use requirement for patients to be in normal sinus rhythm.

DeviceOptimizer Smart System and Optimizer Smart Mini System
Generic NameImplantable Pulse Generator
ApplicantImpulse Dynamics (USA), Inc.
Date Received2021-06-24
Decision Date2021-10-06
PMAP180036
SupplementS008
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
S010 2021-09-16 Normal 180 Day Track No User Fee
S009
S008 2021-06-24 Normal 180 Day Track
S007 2020-09-09 Normal 180 Day Track
S006 2020-06-22 Normal 180 Day Track
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
00810003380050 P180036 000
00810003380043 P180036 000

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