OPTIMIZER Smart, OPTIMIZER Smart Mini

FDA Premarket Approval P180036 S015

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

DeviceOPTIMIZER Smart, OPTIMIZER Smart Mini
Generic NameImplantable Pulse Generator
ApplicantImpulse Dynamics (USA), Inc.30 Ramland Road South, Suite 204orangeburg, NY 10962 PMA NumberP180036 Supplement NumberS015 Date Received07/22/2022 Decision Date08/18/2022 Product Code QFV  Advisory Committee Cardiovascular Supplement Typenormal 180 Day Track No User Fee Supplement Reason Postapproval Study Protocol Expedited Review Granted? No
Date Received2022-07-22
Decision Date2022-08-18
PMAP180036
SupplementS015
Product CodeQFV 
Advisory CommitteeCardiovascular
Supplement TypeNormal 180 Day Track No User Fee
Supplement ReasonPostapproval Study Protocol
Expedited ReviewNo
Combination ProductNo
Applicant AddressImpulse Dynamics (USA), Inc.
30 Ramland Road South, Suite 204
orangeburg, NY 10962 PMA NumberP180036 Supplement NumberS015 Date Received07/22/2022 Decision Date08/18/2022 Product Code QFV  Advisory Committee Cardiovascular Supplement Typenormal 180 Day Track No User Fee Supplement Reason Postapproval Study Protocol Expedited Review Granted? No Combination ProductNo Approval Order Statement  
Approval Of The Revised Conditions Of Approval For Nonclinical MR Testing.

Supplemental Filings

Supplement NumberDateSupplement Type
P180036Original 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 IDPMASupp
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

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