ALTRUA 2 (Models S701, S702, S722); ESSENTIO (Models L100, L101, L121); PROPONENT (Models L200, L201, L221); ACCOLADE
FDA premarket approval N970003/S300 · decided 2025-07-11
Approval details
- PMA number
- N970003
- Supplement
- S300
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- ALTRUA 2 (Models S701, S702, S722); ESSENTIO (Models L100, L101, L121); PROPONENT (Models L200, L201, L221); ACCOLADE
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Applicant
- Boston Scientific Corp
- Date received
- 2025-05-20
- Decision date
- 2025-07-11
- Days to decision
- 52 days
- Decision code
- APPR
- Product code
- LWP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- approval for Software Maintenance Release (SMR) 5 for the ACCOLADE family of pacemakers and CRT-Ps and the associated Model 3869 Brady programmer software application on the Model 3300 LATITUDE Programming System
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510(k) clearances by this applicant
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| 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 |
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| 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 |