MOMENTUM CRT-D IS1 DF4 IS1 (G124, G125); MOMENTUM CRT-D IS1 DF1 LV1 (G126); MOMENTUM X4 CRT-D IS1 DF1 IS4 (G128, G138
FDA premarket approval P010012/S613 · decided 2026-07-23
Approval details
- PMA number
- P010012
- Supplement
- S613
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- MOMENTUM CRT-D IS1 DF4 IS1 (G124, G125); MOMENTUM CRT-D IS1 DF1 LV1 (G126); MOMENTUM X4 CRT-D IS1 DF1 IS4 (G128, G138
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Applicant
- Boston Scientific Corp
- Date received
- 2026-06-26
- Decision date
- 2026-07-23
- Days to decision
- 27 days
- Decision code
- OK30
- Product code
- NIK
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- to add a functionally equivalent alternate vapor degreasing solvent used to remove contaminants from pulse generator components
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|---|---|---|
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| 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 |