FRONTIER/FRONTIER II CRT-P PACEMAKERS
FDA premarket approval P030035/S032 · decided 2007-06-15
Approval details
- PMA number
- P030035
- Supplement
- S032
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- FRONTIER/FRONTIER II CRT-P PACEMAKERS
- Generic name
- Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
- Applicant
- ABBOTT MEDICAL
- Date received
- 2007-05-16
- Decision date
- 2007-06-15
- Days to decision
- 30 days
- Decision code
- OK30
- Product code
- NKE
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Sylmar, CA
- Statement
- MODIFICATIONS TO THE MANUFACTURING PROCESS OF DISPENSING EPOXY ON A COMPONENT LOCATED ON THE PACEMAKER HYBRID.
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