Atlas FDA

Ambicor Inflatable Penile Prosthesis (IPP), AMS 700 IPP

FDA premarket approval N970012/S145 · decided 2018-04-06

Approval details

PMA number
N970012
Supplement
S145
Supplement type
Special (Immediate Track)
Supplement reason
Labeling Change - Indications/instructions/shelf life/tradename
Trade name
Ambicor Inflatable Penile Prosthesis (IPP), AMS 700 IPP
Generic name
Prosthesis, penis, inflatable
Applicant
Boston Scientific Corp
Date received
2018-03-12
Decision date
2018-04-06
Days to decision
25 days
Decision code
APPR
Product code
JCW
Advisory committee
Gastroenterology, Urology
Expedited review
No
Location
Marlboro, MA
Statement
Approval for the addition to the labeling of adverse events (bleeding, exposure to biohazardous material, hemorrhage, improper size, pain, perforation, injury, prolonged procedure, supersonic transporter, unretrieved device fragment).

Class III intelligence, same tools

PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.

510(k) clearances by this applicant

RecordFirmDate
IceSeed 1.5 CX Straight Needle (H7493968333170); IceSphere1.5 CX Straight Needle (H7493968435730); IceRod 1.5 CX Straight Needle (H7493968535330) (K243245)Boston Scientific Corp2024-10-18
LUX-Dx II (M302); LUX-Dx II+ (M312) (K231328)Boston Scientific Corp2023-08-19
WALLSTENT RP Endoprosthesis Transhepatic Biliary, WALLSTENT Endoprosthesis Transhepatic Biliary (K152853)Boston Scientific Corp2015-11-20
AXIOS Stent with Electrocautery Enhanced Delivery System (K150692)Boston Scientific Corp2015-08-05
XXL Vascular Balloon Dilatation Catheter (K150303)Boston Scientific Corp2015-06-15
Chariot Guiding Sheath (K150186)Boston Scientific Corp2015-06-05
EndoVive Initial Placement Standard PEG Kit with ENFit Connector, EndoVive Initial Placement Safety PEG Kit with ENFit Connector (K150679)Boston Scientific Corp2015-05-29
JAGWIRE HIGH PERFORMANCE GUIDWIRE (K141820)Boston Scientific Corp2014-10-21