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.

• Device: OPTIMIZER Smart System (2-Lead configuration)
• Generic Name: Implantable Pulse Generator
• Applicant: Impulse Dynamics (USA), Inc.
• Date Received: 2020-06-22
• Decision Date: 2020-12-30
• PMA: P180036
• Supplement: S006
• Product Code: QFV
• Advisory Committee: Cardiovascular
• Supplement Type: Normal 180 Day Track
• Supplement Reason: Labeling Change - Indications/instructions/shelf Life/tradename
• Expedited Review: No
• Combination Product: No
• Applicant Address: Impulse Dynamics (USA), Inc. 30 Ramland Road South, Suite 204 orangeburg, NY 10962

Supplemental Filings

Supplement Number	Date	Supplement Type
P180036		Original Filing
S015	2022-07-22	Normal 180 Day Track No User Fee
S014
S013
S012
S011	2021-09-28	Real-time Process
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 ID	PMA	Supp
00810003380029	P180036	000
00810003380012	P180036	000
00810003380005	P180036	000
00810003380050	P180036	000
00810003380043	P180036	000
00810003380074	P180036	007
00810003380067	P180036	007
00810003380081	P180036	007
00810003380098	P180036	007
00810003380142	P180036	021
00810003380135	P180036	021