FRONTIER AND FRONTIER II FAMILIES OF PACEMAKERS
FDA premarket approval P030035/S040 · decided 2008-04-04
Approval details
- PMA number
- P030035
- Supplement
- S040
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- FRONTIER AND FRONTIER II FAMILIES OF PACEMAKERS
- Generic name
- Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
- Applicant
- ABBOTT MEDICAL
- Date received
- 2008-02-15
- Decision date
- 2008-04-04
- Days to decision
- 49 days
- Decision code
- APPR
- Product code
- NKE
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Sylmar, CA
- Statement
- APPROVAL FOR A MANUFACTURING SITE LOCATED AT ST. JUDE MEDICAL PUERTO RICO, CAGUAS, PUERTO RICO, FOR FINAL MANUFACTURING OPERATIONS, EXCLUDING STERILIZATION.
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