AMS 700 Series Product Line/ Inflatable Penile Prosthesis (IPP) with and without InhibiZone Treatment

Prosthesis, Penis, Inflatable

FDA Premarket Approval N970012 S168

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

A process change to add the boston scientific st. Paul facility as an alternate manufacturing site for silicone molded components

DeviceAMS 700 Series Product Line/ Inflatable Penile Prosthesis (IPP) with and without InhibiZone Treatment
Classification NameProsthesis, Penis, Inflatable
Generic NameProsthesis, Penis, Inflatable
ApplicantBoston Scientific Corp.
Date Received2019-10-31
Decision Date2019-11-27
PMAN970012
SupplementS168
Product CodeJCW
Advisory CommitteeGastroenterology/Urology
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address Boston Scientific Corp. 100 Boston Scientific Way marlborough, MA 01752

Supplemental Filings

Supplement NumberDateSupplement Type
N970012Original Filing
S168 2019-10-31 30-day Notice
S167 2019-08-22 30-day Notice
S166 2019-07-31 30-day Notice
S165 2019-06-14 30-day Notice
S164
S163
S162 2019-03-21 30-day Notice
S161 2019-03-12 Normal 180 Day Track No User Fee
S160
S159 2019-02-25 30-day Notice
S158
S157
S156 2019-01-18 30-day Notice
S155 2019-01-16 30-day Notice
S154
S153 2018-11-14 30-day Notice
S152 2018-10-23 30-day Notice
S151 2018-10-15 Real-time Process
S150 2018-09-28 Real-time Process
S149 2018-09-27 30-day Notice
S148 2018-08-21 30-day Notice
S147 2018-06-25 30-day Notice
S146 2018-06-19 135 Review Track For 30-day Notice
S145 2018-03-12 Special (immediate Track)
S144 2018-01-16 30-day Notice
S143 2018-01-08 30-day Notice
S142 2017-11-22 30-day Notice
S141 2017-11-22 30-day Notice
S140 2017-11-22 30-day Notice
S139 2017-09-27 Real-time Process
S138 2017-09-08 30-day Notice
S137 2017-07-17 30-day Notice
S136 2017-06-29 Real-time Process
S135 2017-05-17 Special (immediate Track)
S134 2017-04-12 30-day Notice
S133 2017-03-16 30-day Notice
S132 2017-03-15 30-day Notice
S131 2017-02-27 Real-time Process
S130 2017-02-21 30-day Notice
S129 2017-02-06 135 Review Track For 30-day Notice
S128 2017-01-30 Real-time Process
S127 2017-01-12 135 Review Track For 30-day Notice
S126 2016-12-27 135 Review Track For 30-day Notice
S125 2016-12-05 30-day Notice
S124 2016-11-29 30-day Notice
S123 2016-11-23 30-day Notice
S122 2016-11-21 30-day Notice
S121 2016-11-09 Real-time Process
S120 2016-11-04 30-day Notice
S119 2016-09-29 135 Review Track For 30-day Notice
S118 2016-09-19 Real-time Process
S117 2016-07-05 30-day Notice
S116 2016-06-06 30-day Notice
S115 2016-05-05 30-day Notice
S114 2016-04-22 135 Review Track For 30-day Notice
S113 2015-09-30 Special (immediate Track)
S112 2015-09-29 30-day Notice
S111 2015-09-18 135 Review Track For 30-day Notice
S110 2015-07-15 Special (immediate Track)
S109 2015-06-05 30-day Notice
S108 2015-04-08 30-day Notice
S107 2015-03-16 30-day Notice
S106 2015-03-16 30-day Notice
S105 2015-02-27 135 Review Track For 30-day Notice
S104 2015-01-12 30-day Notice
S103 2015-01-09 Real-time Process
S102 2014-11-03 Real-time Process
S101 2014-10-20 30-day Notice
S100 2014-10-09 30-day Notice
S099 2014-07-01 135 Review Track For 30-day Notice
S098 2013-12-05 30-day Notice
S097 2013-11-26 135 Review Track For 30-day Notice
S096 2013-07-16 Special (immediate Track)
S095 2012-12-06 30-day Notice
S094 2012-11-20 Real-time Process
S093 2012-09-10 30-day Notice
S092 2012-07-03 30-day Notice
S091
S090 2012-04-02 30-day Notice
S089 2011-09-28 30-day Notice
S088 2011-08-22 30-day Notice
S087 2011-07-29 30-day Notice
S086 2010-12-03 30-day Notice
S085 2010-11-26 30-day Notice
S084 2010-11-18 Special (immediate Track)
S083 2010-11-17 Normal 180 Day Track
S082 2010-11-17 30-day Notice
S081 2010-11-12 30-day Notice
S080
S079
S078 2010-07-27 30-day Notice
S077
S076
S075
S074
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S001

NIH GUDID Devices

Device IDPMASupp
00878953009872 N970012 139
00878953009827 N970012 139
00878953009834 N970012 139
00878953009841 N970012 139
00878953009865 N970012 139
00878953009872 N970012 139
00878953009780 N970012 139
00878953009797 N970012 139
00878953009803 N970012 139
00878953009810 N970012 139
00878953009827 N970012 139
00878953009834 N970012 139
00878953009841 N970012 139
00878953009858 N970012 139
00878953009865 N970012 139
00878953009810 N970012 139

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