PMA P150035S034

Device: Aveir DR Delivery Catheter (LSCD201)
Applicant: ABBOTT MEDICAL
PMA number: P150035
Supplement: S034
Product code: PNJ
Decision date: 2026-02-23
Classification: Cardiovascular
Generic name: Leadless pacemaker
Approval order statement: approval for a manufacturing site located at Abbott Medical, Interior Lot A Road #2 Km 67.5 Santana Industrial Park Arecibo, Puerto Rico 00612 FEI: 3006705815 for manufacturing, packaging and EO sterilization.

Current openFDA PMA Record#

Device: Aveir DR Delivery Catheter (LSCD201)
Applicant: ABBOTT MEDICAL
PMA number: P150035
Supplement: S034
Product code: PNJ
Generic name: Leadless pacemaker
Decision date: 2026-02-23
Decision code: APPR
Date received: 2025-11-20
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Location Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: approval for a manufacturing site located at Abbott Medical, Interior Lot A Road #2 Km 67.5 Santana Industrial Park Arecibo, Puerto Rico 00612 FEI: 3006705815 for manufacturing, packaging and EO sterilization.