Fortify AssuraTM DR [CD2359-40Q, CD2359-40QC, MR Conditional]
Class D (high risk) · MDIR-0000202 · Physiomed (Pvt) Ltd.
DRAP REGISTERED MEDICAL DEVICE
Fortify AssuraTM DR [CD2359-40Q, CD2359-40QC, MR Conditional] is registered with DRAP under number MDIR-0000202 as a Class D (high risk) medical device, imported. The listed holder is Physiomed (Pvt) Ltd.. Its listed renewal date (27 Feb 2024) has passed, so ask the supplier for the renewal letter.
Screening result
MDIR-0000202 · the class is taken from DRAP's list for this number
DRAP registered Class B/C/D list, 28 Aug 2025
It may have been renewed after DRAP's last list. Ask the vendor for the renewal letter.
ELI-00199
| Device | Fortify AssuraTM DR [CD2359-40Q, CD2359-40QC, MR Conditional] |
|---|---|
| Class | D |
| Listed holder | Physiomed (Pvt) Ltd. |
| Holder address | 268/3, Kamal Road, Saddar,Rawalpindi., Godown Address: Same as above |
| Manufacturing site | M/s St. Jude Medical Cardiac Rhythm Management Division, 15900 Valley View Ct Sylmar, CA 91342, USA M/s St. Jude Medical, Puerto Rico, LLC Lot a Interior No.2, St KM 67.5, Santana Industrial Park Arecibo, PR 00612, USA M/s St. Jude Medical Operations (M) SDN BHD Plot 102, Lebuhraya Kampung Jawa Bayan Lepas Industrial Zone Penang, Pulau Pinang 11900, Malaysia |
| Issued | 28 Feb 2019 |
| Renewal date | 27 Feb 2024 |
| Licence | ELI-00199 |
Specifications
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Screened 7 Oct 2026, 04:09 (Pakistan time). A screening aid, not an official DRAP verification.
More devices from this holder
Other DRAP registrations and enlistments listed for the same company.
| MDIR-0000200 | Endurity Core CRT-Ps Implantabale Cardiac Pulse Generators (Pacemakers) [PM1152, PM2152] | Class D |
| MDIR-0000201 | Endurity MRI (CRT-Ps) Implantabale Cardiac Pulse Generators (Pacemakers) [PM1172, PM2172] | Class D |
| MDIR-0000203 | Ellipse TM VR [CD1377-36Q, CD1377-36QC] | Class D |
| MDIR-0000204 | Quadra Allure MP RF CRT-P) [PM 3262] | Class D |
| MDIR-0000205 | Tendril STS Implantable Cardiac Pacing Leads (Bradycardia and Left Heart Leads) [2088TC] | Class D |
| MDIR-0000206 | Quadra Assura TM [CD3367-40, CD3367-40C] | Class D |
| MDIR-0000207 | Durata TM [7121Q-58, 7120Q-65] | Class D |
| MDIR-0000208 | Quartet TM [1456Q-75] | Class D |
| MDIR-0000726 | CPS AimTM SL (Sittable Inner Catheter) with integrated valve | Class D |
| MDIR-0000727 | Advisor FL Circular Mapping Catheter, Sensor Enabled (Circular Mapping Catheter) | Class D |
| MDIR-0000728 | Livewire Streerable Electrophysiology Catheter | Class D |
| MDIR-0000729 | FlexAbility Sensor Enabled Catheter | Class D |
Corrections
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Source: DRAP's published provisional lists. A screening aid, not an official DRAP verification; confirm with DRAP and the supplier's original documents.
