PALMAZ MULLINS XD Pulmonary Stent
FDA premarket approval P220004/S002 · decided 2024-09-05
Approval details
- PMA number
- P220004
- Supplement
- S002
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- PALMAZ MULLINS XD Pulmonary Stent
- Generic name
- Pulmonary stent
- Applicant
- Cordis US Corp
- Date received
- 2024-08-06
- Decision date
- 2024-09-05
- Days to decision
- 30 days
- Decision code
- OK30
- Product code
- QWC
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Miami Lakes, FL
- Statement
- an updated packaging configuration without physical Instructions for Use
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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 |