TAPSYSTEM 2A
FDA premarket approval P840002/S007 · decided 1997-10-03
Approval details
- PMA number
- P840002
- Supplement
- S007
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- TAPSYSTEM 2A
- Generic name
- SYSTEM, ESOPHAGEAL PACING
- Applicant
- Cardiocommand, Inc.
- Date received
- 1995-10-02
- Decision date
- 1997-10-03
- Days to decision
- 732 days
- Decision code
- APPR
- Product code
- LPA
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Tampa, FL
- Statement
- Approval for a manufacturing site lcoated at Haller Industries, Inc. 4895 West Waters, Suite J, Tampa Florida.
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