VENTAK AND CONTAK CD FAMILIES OF ICDS
FDA premarket approval P010012/S116 · decided 2006-04-12
Approval details
- PMA number
- P010012
- Supplement
- S116
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- VENTAK AND CONTAK CD FAMILIES OF ICDS
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Applicant
- Boston Scientific Corp
- Date received
- 2006-03-06
- Decision date
- 2006-04-12
- Days to decision
- 37 days
- Decision code
- APPR
- Product code
- LWP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- APPROVAL FOR MODIFICATIONS TO THE LABELING FOR THE VENTAK (P960040) AND CONTAK CD (P010012) FAMILIES OF IMPLANTABLE DEFIBRILLATORS TO INCLUDE INFORMATION REGARDING BEHAVIOR OF THESE DEVICES ATTRIBUTABLE TO THE SVO (SILVER VANADIUM OXIDE) USED TO POWER THEM. SPECIFICALLY, AN UPDATE TO THE SYSTEM GUIDE TO INCLUDE LANGUAGE TO IDENTIFY AS NORMAL AN INCREASED CHARGED TIME IN MIDLIFE DUE TO THE INHERENT CHARACTERISTICS OF THE SVO BATTERIES USED.
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510(k) clearances by this applicant
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|---|---|---|
| IceSeed 1.5 CX Straight Needle (H7493968333170); IceSphere1.5 CX Straight Needle (H7493968435730); IceRod 1.5 CX Straight Needle (H7493968535330) (K243245) | Boston Scientific Corp | 2024-10-18 |
| LUX-Dx II (M302); LUX-Dx II+ (M312) (K231328) | Boston Scientific Corp | 2023-08-19 |
| WALLSTENT RP Endoprosthesis Transhepatic Biliary, WALLSTENT Endoprosthesis Transhepatic Biliary (K152853) | Boston Scientific Corp | 2015-11-20 |
| AXIOS Stent with Electrocautery Enhanced Delivery System (K150692) | Boston Scientific Corp | 2015-08-05 |
| XXL Vascular Balloon Dilatation Catheter (K150303) | Boston Scientific Corp | 2015-06-15 |
| Chariot Guiding Sheath (K150186) | Boston Scientific Corp | 2015-06-05 |
| EndoVive Initial Placement Standard PEG Kit with ENFit Connector, EndoVive Initial Placement Safety PEG Kit with ENFit Connector (K150679) | Boston Scientific Corp | 2015-05-29 |
| JAGWIRE HIGH PERFORMANCE GUIDWIRE (K141820) | Boston Scientific Corp | 2014-10-21 |