REGENCY SC, SC+, AND SCX FAMILY OF PULSE GENERATORS
FDA premarket approval P880006/S028 · decided 1998-10-15
Approval details
- PMA number
- P880006
- Supplement
- S028
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- REGENCY SC, SC+, AND SCX FAMILY OF PULSE GENERATORS
- Generic name
- implantable pacemaker Pulse-generator
- Applicant
- St. Jude Medical, Inc.
- Date received
- 1998-09-09
- Decision date
- 1998-10-15
- Days to decision
- 36 days
- Decision code
- OK30
- Product code
- DXY
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Sylmar, CA
- Statement
- The 30-day Notice requested approval for use of parametric release as an alternate to the current use of biological indicators in the release of sterilized products.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.
510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| Advisor HD Grid Mapping Catheter, Sensor Enabled (K172393) | St. Jude Medical, Inc. | 2018-04-23 |
| Confirm Rx Insertable Cardiac Monitor (ICM) System (K163407) | St. Jude Medical, Inc. | 2017-09-29 |
| PressureWire X Guidewire (K161171) | St. Jude Medical, Inc. | 2016-08-15 |
| Nanostim Introducer Kit (K161102) | St. Jude Medical, Inc. | 2016-05-19 |
| The Nanostim Introducer Kit (K160716) | St. Jude Medical, Inc. | 2016-04-14 |
| NANOSTIM INTRODUCER KIT (K140793) | St. Jude Medical, Inc. | 2014-12-17 |
| SJM CONFIRM IMPLANTABLE CARDIAC MONITOR (ICM) (K133481) | St. Jude Medical, Inc. | 2014-05-28 |
| ENLIGHTN RENAL GUIDE CATHETER (K131592) | St. Jude Medical, Inc. | 2014-01-31 |