PMA supplement
P010012 S604: Suture Sleeve Model 4603, 6402, ACUITY X4 Flushing tool/Wire guide Model 4604, Lead Cap Model 6742, Torque Wrench, Mode
FDA PMA supplement · Real-Time Process · Boston Scientific Corp
Key facts
| Original PMA | P010012 |
|---|---|
| Supplement number | S604 |
| Supplement type | Real-Time Process |
| Reason for the supplement | Labeling Change - Indications/instructions/shelf life/tradename |
| Trade name | Suture Sleeve Model 4603, 6402 , ACUITY X4 Flushing tool/Wire guide Model 4604, Lead Cap Model 6742, Torque Wrench, Mode |
| Generic name | Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D) |
| Applicant | Boston Scientific Corp |
| Product code | NIK |
| Received date | Feb 4, 2026 |
| Decision date | Apr 10, 2026 |
At a glance
- No Expedited review granted
- No Approval order on file
- No Summary of safety and effectiveness on file
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About PMA supplements
A PMA supplement asks FDA to approve a change to a device that already holds a premarket approval: a new indication, a design or labeling change, a manufacturing site or process change.
Source: U.S. Food and Drug Administration (FDA), Premarket Approval (PMA) database · Source date: