INCEPTA, ENERGEN, PUNCTUA AND COGNIS CRT-D
FDA premarket approval P010012/S255 · decided 2011-11-17
Approval details
- PMA number
- P010012
- Supplement
- S255
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- INCEPTA, ENERGEN, PUNCTUA AND COGNIS CRT-D
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Applicant
- Boston Scientific Corp
- Date received
- 2010-08-30
- Decision date
- 2011-11-17
- Days to decision
- 444 days
- Decision code
- APPR
- Product code
- LWP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- APPROVAL FOR INCEPTA, ENERGEN. PUNCTUA AND TELIGEN ICD MODELS AND THE INCEPTA, ENERGEN. PUNCTUA AND COGNIS CRT-D MODELS AND PRM SOFTWARE APPLICATION MODEL 2868 AND PULSE GENERATOR SOFTWARE. THE DEVICES AS MODIFIED WILL BE MARKETED UNDER THE TRADE NAMES INCEPTA, ENERGEN, PUNCTUA, TELIGEN AND COGNIS ICD AND CRT-D MODELS AND ARE INDICATED TO PROVIDE VENTRICULAR ANTITACHYCARDIA PACING (ATP) AND VENTRICULAR DEFIBRILLATION FOR AUTOMATED TREATMENT OF LIFE-THREATENING VENTRICULAR ARRHYTHMIASOR FOR PATIE
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
| Record | Firm | Date |
|---|---|---|
| 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 |