AMS 700 SERIES PRODUCT LINE AND THE DYNAFLEX INFLATABLE PENILE PROSTHESES

Prosthesis, Penis, Inflatable

FDA Premarket Approval N970012

This medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original pma or panel track supplement and may not represent the most recent labeling.

Pre-market Approval Supplement Details

Approval for the ams 700 series inflatable penile prosthesis product line. This device is indicated for use in the treatment of chronic, organic, male erectile dysfunction (impotence).

DeviceAMS 700 SERIES PRODUCT LINE AND THE DYNAFLEX INFLATABLE PENILE PROSTHESES
Classification NameProsthesis, Penis, Inflatable
Generic NameProsthesis, Penis, Inflatable
ApplicantBoston Scientific Corp.
Date Received1997-12-22
Decision Date1998-11-02
PMAN970012
SupplementS
Product CodeJCW
Advisory CommitteeGastroenterology/Urology
Expedited ReviewNo
Combination Product No
Applicant Address Boston Scientific Corp. 100 Boston Scientific Way marlborough, MA 01752

Supplemental Filings

Supplement NumberDateSupplement Type
N970012Original Filing
S194 2022-11-01 30-day Notice
S193
S192 2022-08-19 30-day Notice
S191 2022-03-22 30-day Notice
S190 2022-03-15 30-day Notice
S189 2021-08-24 30-day Notice
S188 2021-06-11 30-day Notice
S187 2021-04-30 30-day Notice
S186
S185 2021-02-16 30-day Notice
S184 2020-12-03 30-day Notice
S183 2020-09-29 30-day Notice
S182 2020-08-17 30-day Notice
S181 2020-08-10 30-day Notice
S180 2020-08-07 30-day Notice
S179 2020-07-02 30-day Notice
S178 2020-05-18 30-day Notice
S177 2020-04-20 Normal 180 Day Track No User Fee
S176 2020-03-20 30-day Notice
S175 2020-02-10 30-day Notice
S174 2020-01-23 30-day Notice
S173 2019-11-14 30-day Notice
S172 2019-11-12 30-day Notice
S171 2019-11-12 30-day Notice
S170 2019-11-04 30-day Notice
S169 2019-10-31 30-day Notice
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
S073
S072
S071
S070
S069
S068
S067
S066
S065
S064
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S062
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S047
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S043
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S038
S037
S036
S035
S034
S033
S032
S031
S030
S029
S028
S027
S026
S025
S024
S023
S022
S021
S020
S019
S018
S017
S016
S015
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S013
S012
S011
S010
S009
S008
S007
S006
S005
S004
S003
S002
S001

NIH GUDID Devices

Device IDPMASupp
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00878953009872 N970012 139
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00191506021603 N970012 197
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00191506021221 N970012 197

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