Percutaneous Transluminal Angioplasty Catheter - India CDSCO Medical Device Registration

Percutaneous Transluminal Angioplasty Catheter is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2019/000511_159f1c310eed0f0711fd8c25ce58c4fc_59db8b01d4b979dc186e428a4c210337. This device is marketed under the brand name PTA. The license holder is Abbott Healthcare Private Limited, and it is classified as Device Class Class B. The approving authority is CDSCO.

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CDSCO Registered

Class Class B

Percutaneous Transluminal Angioplasty Catheter

UID: IMP/MD/2019/000511_159f1c310eed0f0711fd8c25ce58c4fc_59db8b01d4b979dc186e428a4c210337

Brand Name

PTA

License Holder

Abbott Healthcare Private Limited

Device Class

Class B

Approving Authority

CDSCO

Product Information

The device is indicated to dilate stenoses in femoral, popliteal, infra popliteal and renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. The 2.0 to 4.0 mm balloon diameters are also indicated for post-dilatation of balloon-expandable stents up to 40 mm and self-expanding stents up to 80 mm in the vessels listed above.