PMA supplement
P010012 S500: ACUITY X4 Straight 86CM,95CM, ACUITY X4 Spiral S 86CM, 95CM, ACUITY X4 Spiral L 86CM, L95CM, Accessory Suture Sleeves S
FDA PMA supplement · 30-Day Notice · Boston Scientific Corp
Key facts
| Original PMA | P010012 |
|---|---|
| Supplement number | S500 |
| Supplement type | 30-Day Notice |
| Reason for the supplement | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
| Trade name | ACUITY X4 Straight 86CM ,95CM, ACUITY X4 Spiral S 86CM, 95CM, ACUITY X4 Spiral L 86CM, L95CM, Accessory Suture Sleeves S |
| Generic name | Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D) |
| Applicant | Boston Scientific Corp |
| Product code | NIK |
| Received date | Mar 13, 2019 |
| Decision date | Apr 8, 2019 |
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: