PMA supplement
P950037 S147: SELOX JT 45 /JT53; ST53/ST60;TILDA R45, R53,R60; SAFIO S53, S60; TILDA JT45,53, TILDA T53,60; DRUG ELUTING PERMANENT RIG
FDA PMA supplement · 30-Day Notice · Biotronik, Inc.
Key facts
| Original PMA | P950037 |
|---|---|
| Supplement number | S147 |
| Supplement type | 30-Day Notice |
| Reason for the supplement | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
| Trade name | SELOX JT 45 /JT53; ST53/ST60;TILDA R45, R53,R60; SAFIO S53, S60; TILDA JT45,53, TILDA T53,60; DRUG ELUTING PERMANENT RIG |
| Generic name | Pulse generator, permanent, implantable |
| Applicant | Biotronik, Inc. |
| Product code | NVZ |
| Received date | Feb 4, 2015 |
| Decision date | Feb 20, 2015 |
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: