Atlas FDA

CONTAK RENEWAL TR, CONTAK RENEWAL 3, LEVIAN SE/HE, COGNIS, INCEPTA

FDA premarket approval P010012/S280 · decided 2012-02-16

Approval details

PMA number
P010012
Supplement
S280
Supplement type
Real-Time Process
Supplement reason
Labeling Change - Indications/instructions/shelf life/tradename
Trade name
CONTAK RENEWAL TR, CONTAK RENEWAL 3, LEVIAN SE/HE, COGNIS, INCEPTA
Generic name
Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
Applicant
Boston Scientific Corp
Date received
2012-01-30
Decision date
2012-02-16
Days to decision
17 days
Decision code
APPR
Product code
NIK
Advisory committee
Cardiovascular
Expedited review
No
Location
St Paul, MN
Statement
APPROVAL FOR A SHELF LIFE EXTENSION FROM 4 YEARS TO 5 YEARS FOR THE SUBJECT LV-1 LEAD PORT PLUG.

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