BLAZER Solid-Tip Ablation Catheter Cable 10, BLAZER Solid-Tip Ablation Catheter Cable 3, INTELLATIP MIFI XP Cable,
FDA premarket approval P020025/S139 · decided 2024-04-05
Approval details
- PMA number
- P020025
- Supplement
- S139
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- BLAZER Solid-Tip Ablation Catheter Cable 10, BLAZER Solid-Tip Ablation Catheter Cable 3, INTELLATIP MIFI XP Cable,
- Generic name
- catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
- Applicant
- Boston Scientific
- Date received
- 2023-06-21
- Decision date
- 2024-04-05
- Days to decision
- 289 days
- Decision code
- APPR
- Product code
- OAD
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- manufacturing site transfer for the Rx Sterile Catheter Cables and Non-Sterile Recording System Electrogram (EGM) Cable to Amphenol Alden Products Company in Hermosillo, Mexico; Amphenol Alden Products Company in Shenzhen, China; and Carrio Cabling Corporation in Colorado Springs, Colorado
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.