OPTIMIZER Smart System (2-Lead configuration)

FDA Premarket Approval P180036 S006

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 mr conditional labeling for the optimizer smart when combined with certain market approved pacing leads.

DeviceOPTIMIZER Smart System (2-Lead configuration)
Generic NameImplantable Pulse Generator
ApplicantImpulse Dynamics (USA), Inc.
Date Received2020-06-22
Decision Date2020-12-30
PMAP180036
SupplementS006
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
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
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00810003380043 P180036 000
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00810003380012 P180036 000
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00810003380029 P180036 000
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00810003380029 P180036 000
00810003380012 P180036 000
00810003380005 P180036 000
00810003380029 P180036 000
00810003380012 P180036 000
00810003380005 P180036 000
00810003380029 P180036 000
00810003380012 P180036 000
00810003380005 P180036 000
00810003380012 P180036 000
00810003380005 P180036 000
00810003380012 P180036 000
00810003380005 P180036 000
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00810003380012 P180036 000
00810003380005 P180036 000
00810003380029 P180036 000
00810003380012 P180036 000
00810003380005 P180036 000
00810003380029 P180036 000
00810003380005 P180036 000
00810003380029 P180036 000
00810003380012 P180036 000
00810003380005 P180036 000
00810003380029 P180036 000
00810003380012 P180036 000
00810003380005 P180036 000
00810003380029 P180036 000
00810003380012 P180036 000
00810003380029 P180036 000

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