ATTAIN PERFORMA
FDA premarket approval P080006/S078 · decided 2015-04-28
Approval details
- PMA number
- P080006
- Supplement
- S078
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- ATTAIN PERFORMA
- Generic name
- Drug eluting permanent left ventricular (lv) pacemaker electrode
- Applicant
- Medtronic, Inc.
- Date received
- 2015-04-03
- Decision date
- 2015-04-28
- Days to decision
- 25 days
- Decision code
- OK30
- Product code
- OJX
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- THE FOLLOWING MANUFACTURING CHANGES:1) THE ADDITION OF AN ALTERNATIVE TESTING SYSTEM FOR ELECTRODE COMPONENTS; 2) USE OF FACTORYWORKS RELEASE 7.9 MANUFACTURING SOFTWARE; 3) A REDUCTION IN THE EXPOSURE TIME DURING ETHYLENE OXIDE HALF-CYCLE TESTING; 4) A REDUCTION IN THE FREQUENCY OF ENVIRONMENTAL MONITORING TESTING IN SPECIFICMANUFACTURING AREAS; 5) AN UPDATE TO THE MAXIMUM STERILIZATION LOAD PROFILE TEMPERATURE; AND 6) USE OF FACTORYWORKS RELEASE 7.11 MANUFACTURING SOFTWARE.
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 |
|---|---|---|
| VitalFlow Set with Balance™ Biosurface (K261335) | Medtronic, Inc. | 2026-07-31 |
| Concerto Versa™ Detachable Coil (K261866) | Medtronic, Inc. | 2026-06-24 |
| Elongated One-Piece Arterial (EOPA) 3D™ Arterial Cannulae (K260195) | Medtronic, Inc. | 2026-04-23 |
| Retrograde Coronary Sinus Perfusion Cannulae (K253203) | Medtronic, Inc. | 2026-02-19 |
| Clearview Intracoronary Shunts (K253998) | Medtronic, Inc. | 2026-01-20 |
| Bio-Medicus Life Support Catheter and Introducer (K251831) | Medtronic, Inc. | 2026-01-15 |
| Concerto Versa™ Detachable Coil (K253511) | Medtronic, Inc. | 2026-01-14 |
| C320LBB Delivery System (C320LBBS45), C320LBB Delivery System (C320LBBS48), C320LBB Delivery System (C320LBBL45), C320LBB Delivery System (C320LBBL48) (K253409) | Medtronic, Inc. | 2025-12-19 |