PALMAZ MULLINS XD Pulmonary Stent
FDA premarket approval P220004/S001 · decided 2023-11-02
Approval details
- PMA number
- P220004
- Supplement
- S001
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol
- Trade name
- PALMAZ MULLINS XD Pulmonary Stent
- Generic name
- Pulmonary stent
- Applicant
- Cordis US Corp
- Date received
- 2023-09-19
- Decision date
- 2023-11-02
- Days to decision
- 44 days
- Decision code
- APPR
- Product code
- QWC
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Miami Lakes, FL
- Statement
- Approval of the protocol for the post-approval study (PAS) referenced above. The PAS protocol has been submitted to comply with the conditions of approval outlined in our approval order for P220004.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| Cordis BRITECROSS Support Catheter (K233637) | Cordis US Corp | 2024-06-28 |
| INFINITI™ Ambi Angiographic Catheter (K232573) | Cordis US Corp | 2023-11-21 |
| RAIN Sheath™ Tibial Pedal Introducer (K230704) | Cordis US Corp | 2023-04-24 |
| SABER .014 PTA Dilatation Catheter; SABERX .014 PTA Dilatation Catheter (K221832) | Cordis US Corp | 2022-08-22 |