PMA P840002S011
- Device
- STAT PACE II
- Applicant
- Cardiocommand, Inc.
- PMA number
- P840002
- Supplement
- S011
- Product code
- LPA
- Decision date
- 2004-10-01
- Classification
- System, Esophageal Pacing
- Generic name
- SYSTEM, ESOPHAGEAL PACING
- Approval order statement
- APPROVAL FOR MANUFACTURING SITES LOCATED AT MARTECH MEDICAL PRODUCTS, BAJA CALIFORNIA, MEXICO AND HARLEYSVILLE, PENNSYLVANIA.
Current openFDA PMA Record#
- Device
- STAT PACE II
- Applicant
- Cardiocommand, Inc.
- PMA number
- P840002
- Supplement
- S011
- Product code
- LPA
- Generic name
- SYSTEM, ESOPHAGEAL PACING
- Decision date
- 2004-10-01
- Decision code
- APPR
- Date received
- 2004-03-09
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Express GMP Supplement
- Approval order statement
- APPROVAL FOR MANUFACTURING SITES LOCATED AT MARTECH MEDICAL PRODUCTS, BAJA CALIFORNIA, MEXICO AND HARLEYSVILLE, PENNSYLVANIA.