GUARDIAN(R) ATP II IMPLANTABLE CARDIOVERTER/DIFIB.
FDA premarket approval P940024 · decided 1997-07-03
Approval details
- PMA number
- P940024
- Trade name
- GUARDIAN(R) ATP II IMPLANTABLE CARDIOVERTER/DIFIB.
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Telectronics Pacing Systems, Inc.
- Date received
- 1994-07-08
- Decision date
- 1997-07-03
- Days to decision
- 1091 days
- Decision code
- APPR
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Englewood, CO
- Statement
- APPROVAL FOR THE GUARDIAN(TM) ATP II MODEL 4211 IMPLANTABLE CARDIOVERTER/DEFIBRILLATOR SYSTEM. THE GUARDIAN(TM) ATP II MODEL 4211 IMPLANTABLE CARDIOVERTER DEFIBRILLATOR HEREAFTER REFERRED TO AS THE 4211 IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SYSTEM CONSISTS OF THE FOLLOWING: THE GUARDIAN(TM) ATP II MODEL 4211 IMPLANTABLE CARDIOVERTER DEFBRILLATOR; IMPLANTABLE DEFIBRILLATOR PATCH LEAD MODEL 040-105, 040-106, 040-107, 040-128, 040-129 AND 040-130; MODEL 4510 IMPLANT SUPPORT DEVICE; GENERIC 4211 PE
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| MAXIM PF MODELS 033-581/033-590 (K961118) | Telectronics Pacing Systems, Inc. | 1996-07-15 |
| STERILIZATION (K943657) | Telectronics Pacing Systems, Inc. | 1996-06-24 |
| BIFURCATED LEAD ADAPTORS, 3.2MM & 5.0 MM (K934899) | Telectronics Pacing Systems, Inc. | 1994-05-12 |
| NEW LEAD INTRODUCER KITS, VARIOUS MODELS (K926340) | Telectronics Pacing Systems, Inc. | 1993-05-27 |
| NEW EXTRUSION VENDOR FOR POLYURETHANE TUBING (K914489) | Telectronics Pacing Systems, Inc. | 1992-08-17 |
| UNIVERSAL TERMINAL CAP, 3.2MM (K913919) | Telectronics Pacing Systems, Inc. | 1991-12-31 |
| UNIPOLAR UPSIZING ADAPTOR (K912773) | Telectronics Pacing Systems, Inc. | 1991-10-23 |
| 100 CM PERMANENT PACING LEAD MODELS (K911273) | Telectronics Pacing Systems, Inc. | 1991-08-28 |